January 2025 Newsletter

In the Spotlight

At the MRCT Center, we recognize that recent U.S. federal actions and proposals may raise concerns among our stakeholders. In these moments of uncertainty, we reaffirm our unwavering dedication to our mission: to improve the integrity, safety, and rigor of global clinical trials.

For 15 years, the MRCT Center has served as a trusted convener, bringing together a network of global stakeholders—including industry, academia, nonprofit organizations, advocacy groups, and regulatory agencies—to develop and implement ethical, actionable, and practical solutions for clinical research. This spirit of collaboration and our commitment to transparency and integrity are cornerstones of our work, enabling us to address critical challenges in advancing health, access, and innovation. We will continue to provide guidance, advocate for actionable practices, and foster solutions grounded in science, ethics, and public health that benefit patients, researchers, and communities across the globe.


Workshop: Opportunities to Engage and Retain Talent in the Clinical Research Workforce

The Convergence Project is pleased to invite you to an upcoming virtual event, hosted by the MRCT Center, focused on workforce development strategies to support a more dynamic and competitive clinical research workforce.

Event Details:
Date: Tuesday, February 25, 2025
Time: 10:00 AM – 1:00 PM ET
Location: Online and free to attend

This meeting will bring together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics will include workforce development, targeted recruitment, and actionable steps to drive systemic improvements. You’ll have the opportunity to engage with panelists leading programs in Georgia, North Carolina, West Virginia, and other states across the country.

We hope you can join us for this important conversation. We look forward to your participation!


Webinar: Global Development of a Clinical Research Workforce: Tools and Resources

Join us for a webinar dedicated to Global Workforce Development: Tools and Resources, featuring the keynote speaker Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). We then highlight the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities of recruiting and retaining a diverse and capable workforce. Sally Armstrong, CEO of PRAXIS Australia, will share how PRAXIS Australia has used the JTF Framework in their courses, workshops, and immersive onsite training programs. Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), will discuss ACRP’s initiatives to build a diverse and qualified clinical research workforce through training, education, and collaboration, based on the JTF Framework. This webinar will provide actionable and practical strategies to support global clinical trial professionals. 

Event Details:
Date: Thursday, April 3, 2025
Time: 9:00 – 10:00 AM ET
Location: Online and free to attend


Biannual Meeting of the Joint Task Force for Clinical Trial Competency: Resources

The slides and executive summary from the December 10, 2024, biannual meeting of the Joint Task Force for Clinical Trial Competency (JTF) are now available. Highlights include updates on training modules based on the JTF Framework being implemented in the Philippines, Japan, and the ARISE network; workforce training initiatives at clinical sites in Portugal led by ROCHE and AICIB; and efforts in New York City to train community health members using the JTF Framework. The meeting also covered updates on revisions to Domain 6 (Data Management and Informatics), the formation of a new Patients and Participants Task Force, and the exploration of team science competencies as potential expansions of Domains 7 and 8.


December 5: Carolyn Chapman moderated a webinar co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGMTE) Working Group as part of their Lunchtime Learning Series. The panel, “What’s Up with Long-Term Follow-Up: Ethical, Regulatory & Operational Challenges,” captured the ethical, regulatory, and operational challenges of LTFU studies through diverse viewpoints and perspectives.  View the recording here.

December 9: Barbara Bierer moderated a panel at a public Convergence Project webinar on “The State of Diversity in Clinical Trials: Planning for 2025 and Beyond.” The webinar was organized by the Clinical Trials Transformation Initiative (CTTI), MRCT Center, and Milken Institute’s FasterCures, with contributions from the National Academies of Sciences, Engineering, and Medicine. 

January 15: Barbara Bierer was a discussant in the two-hour workshop, “Support of IPD meta-analyses through trusted research environments (TREs),” sponsored by the European Network of Trusted Research Environments EOSC-ENTRUST, funded by Horizon Europe.

February 19-20: Sylvia Baedorf Kassis will present at OHRP’s Research Community Forum in North Augusta, SC, on the theme “Maintaining Public Trust in the Face of Emerging Trends in Research.” She will lead a session on designing consent processes with the participant in mind. Click here to register.

February 21: Sylvia Baedorf Kassis will join the Navigating IRB Community Engagement (NICE) team of Augusta University Institutional Review Board to share at an in-person community forum at the Lucy Craft Laney Museum of Black History entitled “Looking Beyond Tuskegee.” To register, please email Cynthia Riley.

February 25, 10 AM – 1 PM ETOpportunities to Engage and Retain Talent in Clinical Research: Workforce Development. See Spotlight above.

March 11: Sylvia Baedorf Kassis will be a panelist at the DIA Medical Affairs and Science Communications Forum, speaking on using plain language to develop clear communications about clinical trials. Click here to register.

March 17, 5:00-5:45 PM ET: Willyanne DeCormier Plosky will speak on a panel, “Laying the Foundation for Effective and Equitable Representation in Clinical Trials,” at the Patients as Partners Conference in Boston, MA. 

April 3, 9 – 10 AM ET: Global Development of a Clinical Research Workforce: Tools and Resources. See Spotlight above


January 24: Jack Ferdman, David Peloquin, and Barbara Bierer published “New Developments in Right to Try Legislation” in Health Law Weekly. A new iteration of the federal Right to Try (RTT) law is gaining momentum. Like the federal RTT law and grounded in similar principles, RTT 2.0 laws sit outside of FDA purview. This article discusses the federal RTT law in comparison to the U.S. Food and Drug Administration (FDA) expanded access pathway, compares RTT with RTT 2.0, and explores the challenges of each.

January 23: The MRCT Center’s Molly Siegel, Sylvia Baedorf Kassis, and Barbara Bierer published a paper with colleagues at Dana-Farber Cancer Institute and Daegu Catholic University, School of Medicine, entitled “Analysis of the Choice of Control in Acupuncture Clinical Trials Involving Patients with Breast Cancer” in the Journal of Acupuncture Research

January 22: Barbara Bierer and others published “Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov” in Pediatric Research. Analyzing approximately 5000 US pediatric interventional studies registered on ClinicalTrials.gov from 2019 to 2022, 23.4% explicitly included English language requirements in the eligibility criteria and only a small minority provided any justification for the exclusion. Since approximately one-fifth of US households speak a language other than English, this requirement limits access to trials and the generalizability of the research results.

January 15: The NTIA’s proposed rule on the “Ethical Guidelines for Research Using Pervasive Data” aims to increase U.S. privacy protections with a heightened focus on responsible use. In response, the MRCT Center has submitted a public comment recommending enhancing safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address data advancements and mitigate risks to individuals and communities. 

December 31: The NIH’s “2026-2030 Minority Health and Health Disparities Strategic Plan” aims to deepen understanding, enhance research, and improve minority health outcomes by addressing health disparities through targeted goals. In response, the MRCT Center submitted public comments that emphasized the importance of integrating strategies from the National Action Plan for Achieving Diversity in Clinical Trials, addressing structural barriers, fostering trust, and empowering underrepresented communities to achieve equitable health outcomes. 

December 21: Carolyn Chapman and co-author Heini Natri published an article, “Toward Justice and Community Empowerment in Genomics Studies on Sensitive Traits,” in the Hastings Center Report. The authors provide an overview of past and ongoing efforts in community engagement in genomics studies and consider successes and opportunities for further improvement. They set out a vision for a more equitable and collaborative genomics where wider communities, including social, ethnic, and other communities that share a particular trait, are included in the research as peers and collaborators. 

December 13: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for maintaining scientific rigor and data reliability when using real world data (RWD) amidst diverse healthcare settings. The MRCT Center comments addressed data quality when using clinical (and variable) data, ethical and practical challenges of randomization in clinical settings, vulnerabilities in data privacy and security, and participant safety while promoting innovative approaches and pilot programs to refine implementation strategies for this purpose. 

November 29: The DOJ Notice of Proposed Rulemaking (NPRM), “Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” (DOJ-NSD-2024-0004) aims to safeguard sensitive U.S. personal- and government-related data from countries of concern or covered persons, emphasizing national security and data protection. MRCT Center comments highlighted the need to balance these security measures with global health priorities, recommending explicit public health and research exemptions, alignment with international standards, refined definitions, and transparent compliance to support access to health-related data and advancing science, medicine, and individual and public health.


Chloe de Campos joined the MRCT Center in 2023 as a Student Researcher in Creative Design and has since advanced to the role of Graphics and Information Design Specialist. In this capacity, she develops materials to support the Center’s communication and training efforts, including designing infographics, presentations, and interactive media. Chloe holds a bachelor’s degree in computer science from Brown University, where she developed expertise in user-centered interface design, creative problem-solving, and technical communication.


Begonya Nafria Escalera, Head of Patient Engagement in Research at the Paediatric Cancer Center, Sant Joan de Déu in Barcelona, Spain, met with Barbara Bierer and Elisa Koppelman in Boston in December 2024. Their discussions focused on ongoing collaborations to amplify the voices of pediatric patients as partners in the planning, conduct, and support of global clinical trials. By prioritizing the direct representation of adolescents and young adults, these efforts aim to make clinical trials more responsive, appropriate, and considerate of this population’s unique needs.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

November 2024 Newsletter

In the Spotlight

New Resources: Post-Trial Responsibilities: Continued Access

The MRCT Center Post-Trial Responsibilities: Continued Access Taskforce (PTR Taskforce) is pleased to launch an updated Post-Trial Responsibilities: Continued Access website. The site highlights the Taskforce’s ongoing work and new deliverables.

Key updates include:

  • Revised Post-Trial Responsibilities Principles, accompanied by an analysis, offer a principles-based approach to guide actions for providing continued access. The principles and analysis are designed to be read together. 
  • Framework of Responsibilities, offering considerations for sponsors and researchers to make equitable, fair decisions about continued access to investigational products. This framework is intended to support both policy and guidance development. 

Featured Frameworks: 

We thank the PTR Taskforce for their dedication and expertise. In 2025, the Taskforce will address the challenges of post-trial continued access in low- and middle-income countries and low-resource settings.


LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

The compiled LGBTQIA+ Inclusion by Design in Clinical Research Toolkit is now available.

Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the ethical principles of respect for persons, beneficence, and justice, we have developed a toolkit to support the equitable participation of people who are LGBTQIA+.

The toolkit contains seven tools. Anyone can use the toolkit, although the first four tools, released in the spring of 2024, are directed more toward sponsors and research teams, and the latter three, released here, are directed more toward participants. We invite you to explore the toolkit or to find, adapt, and use the tools you find most relevant to your individual and/or organizational journey.

·      LGBTQIA+ Inclusive Imagery Case Study

·      LGBTQIA+ Inclusive Language Checklist

·      SOGI Data Collection Checklist

·      SOGI Data Privacy Checklist

·      Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective

·      Participant Questionnaire Inclusive of the LGBTQIA+ Participant Perspective

·      Exit Survey Inclusive of the LGBTQIA+ Participant Perspective


New Representation in Research Resources

Representation in Research now combines the Diversity, Equity, and Inclusion (DEI) website landing page and microsite and is intuitively organized by sub-project (e.g., population group) rather than by the resource type (e.g., toolkit, webinar). We invite you to explore this comprehensive resource.


New Podcast Episode

Episode 2 of the Trials Beyond Borders podcast is now available on all streaming platforms. In this episode, Racquel Bruton, Associate Director and Clinical Trials Diversity Portfolio Lead at Biogen, and Willyanne DeCormier Plosky, MRCT Center Program Director, discuss how sponsor companies are enhancing representation in clinical trials, particularly outside the US. Racquel highlights Biogen’s longstanding commitment to reaching underrepresented populations and explores how the MRCT Center’s roadmap can help organizations develop effective diversity action plans.

Tune in to learn practical insights on operationalizing diversity strategies, now available on all streaming platforms and here.


Join Us: December Biannual Meeting of the Joint Task Force for Clinical Trial Competency

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.

Upcoming Meeting: The next biannual JTF meeting, open to the public, will occur on December 10, 9–11 AM ET. These virtual meetings are designed to accommodate global partners and stakeholders.

Agenda Highlights:

·      Launch of a participant and patient partner competencies task force.

·      Delphi results from the Data Management Task Force.

·      Proposed team science competencies.

·      Updates on the Portuguese translation of JTF resources.

·      Results from the JTF competency survey conducted in the Philippines.

·      Training community workers using the JTF framework.

Click here to register.


Join us for a Virtual Meeting on Clinical Trial Diversity

On December 9, the MRCT Center, in collaboration with the Clinical Trials Transformation Initiative (CTTI) and Milken Institute’s FasterCures, and with contributions from the National Academies of Sciences, Engineering, and Medicine, will host a virtual meeting to discuss the current state of diversity in clinical trials.

This meeting is part of the ongoing Diversity Convergence Project series, which began in 2023 and will feature insights from community leaders, policymakers, and researchers. Together, we will examine how the post-election policy landscape may impact efforts to enhance diversity in clinical trials.

The webinar is free to attend and will take place from 10:00 am to 1:00 pm ET.

Click here to register.


October 29-30: The MRCT Center hosted a workshop, Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact, in Washington, DC. Supported by MRCT Center sponsors Johnson & Johnson, AstraZeneca, and Sanofi, the two-day event convened 80 pediatric and platform trial experts from Europe, Asia, Australia, and the US. Participants represented diverse stakeholder perspectives, working together to advance thinking on pediatric platform trials as a promising approach to accelerate the delivery of safe and effective medicines for children.

November 1: Willyanne DeCormier Plosky delivered a keynote speech, “Gender Perspectives and Inclusion: Key Elements in Transforming Medical Education for a Future of Personalized and Safe Care,” at the University of Monterrey (Mexico) 2nd International Symposium on Medical Education.

November 2-5: Barbara Bierer and Sarah White attended the ICH E6(R3) Good Clinical Practice and ICH M11 Clinical Electronic Structured Harmonised Protocol Expert Working Group (EWG) meetings in Montreal, Canada. The MRCT Center is an ICH Training Associate and, over the next two years, will develop and design didactic and case-based training courses for these ICH guidelines.

November 7: Barbara Bierer presented the keynote speech, “Out of Site, Out of Mind? Ethical issues in Decentralized Research,” at the 14th annual CCTSI Research Ethics Conference at the Colorado Clinical and Translational Sciences Institute.

November 12: Barbara Bierer presented and moderated “Patient Advocacy in Cell and Gene Therapy” at the Mass General Brigham Gene and Cell Therapy Research Symposium.

November 13-15: The MRCT Center’s Annual Symposium brought together over 120 in-person and approximately 400 virtual registrants worldwide to discuss pressing topics in clinical research. The program, held on the Harvard Medical School campus, featured a keynote address by Dr. Khair ElZarrad, Director of the FDA’s Office of Medical Policy, and highlighted collaborative approaches to advancing equity, innovation, and global harmonization in clinical trials. The event also included the conference Innovations in Data Sharing, which was presented in collaboration with Vivli.

The MRCT Center at PRIM&R Annual Conference:

  • November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Elyse Summers (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) presented “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
  • November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) presented “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?
  • November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky joined Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.
  • November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) presented“Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.
  • November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky presented with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
  • November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky moderated a panel titled “Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel featured Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.

November 20: Barbara Bierer presented “Research Misconduct: New Regulations, prevention, and Integrity” at the Allegany-Singer Research Institute.

December 5: Carolyn Chapman, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor a webinar, “What’s up with Long-Term Follow-Up: ethical, regulatory, operational challenges,” with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine. The webinar is part of PGTME’s fifth annual Lunchtime Lecture Series. 

Click here to register.

December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.

December 10, 12 pm ET: Carolyn Chapman will present “Science Applications and Ethics of Cell and Gene Therapy” at an Institute for Advanced Clinical Trials for Children (I-ACT) webinar. 

Click here to register.

December 12, 9 – 11:30 am ET: Meeting of the Bioethics Collaborative. Topic: Is it Time to Retire the Concept of Deidentification?

January 9, 1:00 – 3:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable. Topic: Recent FDA Guidance Documents on Clinical Trials: Decentralized Clinical Trials, Considerations for Generating Clinical Evidence from Oncology Multi-regional Clinical Development Programs, and Diversity Action Plans.


November 6: Esther Krofah, Morgan Hanger, Sally Okun, and Barbara E. Bierer co-authored an article in Health Affairs Forefront titled Towards A National Action Plan to Improve Representation in Clinical Trials.” The article addresses a critical gap in clinical research: the disproportionate exclusion of underrepresented populations—including Black, Latino, Native American, Asian, and rural communities—who often face higher rates of serious health conditions. This lack of representation limits scientific progress and restricts equitable access to healthcare advancements.

The article builds on the publication Toward a National Action Plan for Achieving Diversity in Clinical Trials, which outlines actionable steps to improve diversity across eight key areas. This work is part of the Diversity Convergence Project, a collaborative effort led by the MRCT Center, Clinical Trials Transformation Initiative, FasterCures, and the National Academies of Sciences. The initiative calls for cross-sector collaboration to create a more inclusive and equitable clinical trial ecosystem.

November 11: A recent Frontiers in Pediatrics article, “Engaging children and adolescents in the design and conduct of paediatric research,” co-authored by Barbara Bierer and Elisa Koppelman, emphasizes the importance of directly involving children and adolescents in pediatric research design and execution, highlighting the benefits of incorporating their perspectives alongside those of parents and guardians. The authors provide theoretical, ethical, and practical recommendations for systematically engaging young participants to enhance the relevance and effectiveness of clinical studies.


Julia Etkin joined the MRCT Center as a Research Assistant II in November 2024. She is managing the Research, Development, and Regulatory Roundtable (R3), Public Comments, and a revision of Protocol Ethics.

Julia is a Dean’s Scholar at Harvard Medical School, pursuing a Master of Science in Bioethics (MBE). She completed her Postgraduate Fellowship at Yale School of Medicine, Department of Internal Medicine, as a Postgraduate Associate with the Center for Outcomes Research and Evaluation (CORE) on the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), the Yale Open Data Access (YODA) Project, and the Bioethics Lab in the Program for Biomedical Ethics. Julia graduated Summa Cum Laude from Union College in Schenectady, NY, earning a Bachelor of Arts in Science, Medicine, and Technology in Culture with Political Science and Law & Humanities. Prior to her current research, Julia worked in biotech in regulatory compliance on medical devices and has experience as a law clerk addressing environmental class action lawsuits


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

October 2024 Newsletter

In the Spotlight

We are delighted to announce that our new course, “Ethics and Review of Interventional Clinical Research,” is now available online at OpenWHO.org. This course was developed in partnership with the World Health Organization and aims to meet the growing demand for training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review interventional clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials.

This course is available free of charge worldwide. Please click here to enroll.


Accessibility 101 Training Series

The MRCT Center developed a series of six Accessibility 101 Training modules to complement the Accessibility by Design (AbD) in Clinical Research Toolkit:

  • Learning About Disability Inclusion
  • Mapping the Participant Journey
  • Creating Alt Text
  • Assessing Color Contrast
  • Using Plain Language
  • Developing Accessible PowerPoints

These training modules are in PowerPoint format. They can be taken on-demand by individuals or utilized by organizations to conduct group training sessions on accessibility and supporting greater inclusion of people with disabilities in clinical research, with permission from and credit to the MRCT Center.

Also, check out our recent webinars on Accessibility 101: How to Write Alt-Text and Map Participant Journeys and Designing PowerPoint Presentations to Support Health Literacy and Accessibility to see how these training modules can be adapted and used for training, advocacy, or planning purposes.


Now On Demand: Health Literacy Month webinar series

In celebration of Health Literacy Month, the MRCT Center hosted three webinars in October focused on integrating health literacy and accessibility best practices when communicating clinical research information to participants. Resources from these sessions, including recordings, slides, and supplementary materials, are now available on demand here.


Join Us: 2024 Annual Symposium

The MRCT Center invites clinical research stakeholders—including professionals, patient participants, and advocates—to the 2024 Annual Symposium, a complimentary event celebrating 15 years of advancing ethical, actionable, and practical solutions for clinical trials. This symposium will bring together diverse voices to explore cutting-edge advancements, regulatory updates, and participant-centered approaches shaping the future of clinical research.

Event Details:

  • Date: November 14–15, 2024
  • Location: Gordon Hall & Countway Library, Harvard Medical School, Boston, MA. A virtual option is also available.
  • Cost: Free to all registrants

Click here to view the full agenda and to register.


Join Us: December Biannual Meeting of the Joint Task Force for Clinical Trial Competency

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

The public is invited to attend biannual meetings; these meetings are virtual to accommodate our global partners and interested parties. The next meeting is December 10 from 9 – 11 AM ET. Proposed updates include the launch of a participant and patient partner competencies task force, Delphi results from the data management task force, proposed team science competencies, experiences with the Portuguese translation, results from the JTF competency survey in the Philippines, and training community workers using the JTF framework.

Click here to register


Celebrating Dr. Bierer’s Leadership in Research Advocacy!

We are thrilled to announce that Barbara Bierer, Faculty Director of the MRCT Center and Professor of Medicine at Harvard Medical School, will receive the Herbert Pardes Family Award for National Leadership in Advocacy for Research at the 2025 Research!America Advocacy Awards.

Dr. Bierer has championed research ethics, design, and international collaboration. Her contributions, including co-founding the MRCT Center and Vivli, have significantly advanced the global standards for clinical trials and data sharing.

She will be formally presented with the award on March 12, 2025, at the National Academy of Sciences in Washington, D.C.

Click here to read more about the 2025 Research!America Advocacy Awards and Dr. Bierer’s fellow honorees.


MRCT Center Joins National Roundtable to Address Clinical Trial Diversity

MRCT Center Program Manager Hayat Ahmed participated in a Clinical Trial Diversity Roundtable hosted by Congresswoman Robin Kelly (IL-02), Chairwoman of the Congressional Black Caucus (CBC) Health Braintrust, at the La Rabida Children’s Hospital in Chicago on October 8. Congresswoman Robin Kelly gathered various healthcare and research stakeholders to hear about their efforts to diversify clinical trials. 

The roundtable addressed critical challenges, particularly the historical mistrust in the Black community stemming from unethical research practices. Participants highlighted ongoing efforts to educate the community and diversify the scientific and medical workforce to restore confidence in the clinical trial process.

Congresswoman Kelly listened to insights from representatives of leading organizations, including the MRCT Center at Brigham and Women’s Hospital and Harvard, Cancer Support Community, Patient-Centered Outcomes Research Institute, Genentech, Howard Brown Health-Sheridan, Bristol Myers Squibb, Walgreens Boots Alliance, City of Hope Chicago, and ATW Health Solutions. Key government partners such as the Illinois Department of Public Health, the Department of Health and Human Services, and the NIH were also present, showcasing a united front in tackling these essential issues.

Click here to read the comments that were presented.


Join us for a Virtual Meeting on Clinical Trial Diversity

On December 9, the MRCT Center, in collaboration with the Clinical Trials Transformation Initiative (CTTI) and Milken Institute’s FasterCures, and with contributions from the National Academies of Sciences, Engineering, and Medicine, will host a virtual meeting to discuss the current state of diversity in clinical trials.

This meeting is part of the ongoing Diversity Convergence Project series, which began in 2023 and will feature insights from community leaders, policymakers, and researchers. Together, we will examine how the post-election policy landscape may impact efforts to enhance diversity in clinical trials.

The webinar is free to attend and will take place from 10:00 am to 1:00 pm ET.

Click here to register.


New ICH E8(R1) Video

The MRCT Center is pleased to announce the availability of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research and quality by design. The MRCT Center is currently developing a series of in-depth training modules to complement the video.

To view the video, click here.


October 8: Willyanne DeCormier Plosky, MRCT Center Program Director, presented with Zary Amirhosseini (Program Manager, Disability Program, Mass General Hospital), Martha Jones (Vice President, Human Research Affairs, Mass General Brigham), and Jeanhee Chung (Principal Investigator, Lab of Computer Science, Mass General Hospital; Instructor in Medicine, Harvard Medical School) on “Empowering Voices: Strategies for Involving Individuals with Disabilities in Research.” This webinar is part of the Chester Pierce Research Society Speaker Series.

October 10: Barbara Bierer and Mark Barnes, Co-Faculty Directors of the MRCT Center, each presented at the University of Pennsylvania’s Symposium entitled, “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity.” Dr. Bierer spoke on “Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct,” and Mr. Barnes addressed “Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions.”

October 10: Now On DemandDesigning Impactful Informed Consent Processes that Empower Participants webinar.

October 17: Now On DemandCreating and Sharing Plain Language Summaries: One Team’s Experience webinar.

October 21: Willyanne DeCormier Plosky presented at Penn State College of Medicine/ Penn State Clinical & Translational Science Institute on “Mapping the Participant Journey: Disability Inclusion in the Research Process.”

October 22: Now On Demand: Designing PowerPoint Presentations to Support Health Literacy and Accessibility webinar.

October 22: Barbara Bierer was invited to join the discussion of “Operationalizing Ethics into Online Safety and AI Research” held by the White House Office of Science and Technology Policy (OSTP) in Washington, DC.

October 31 – November 1: Willyanne DeCormier Plosky will deliver a keynote speech at the University of Monterrey (Mexico) 2nd International Symposium on Medical Education. The keynote title is “Gender Perspectives and Inclusion: Key Elements in Transforming Medical Education for a Future of Personalized and Safe Care.”

Nov 13 – 15: MRCT Center Annual Symposium. Click here to learn more about the agenda and to register.

November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Click here to register for this event or all MRCT Center Annual Symposium events.

The MRCT Center at PRIM&R Annual Conference:

  • November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Michelle Feige (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) will present “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
  • November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) will present “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?
  • November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will join Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.”
  • November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) will present “Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.”
  • November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky will be presenting with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “(E01) Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
  • November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will moderate a panel titled “Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel will feature Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.

December 5: 12-1:15 pm ET: Carolyn Chapman, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor a webinar, “What’s up with Long-Term Follow-Up: ethical, regulatory, operational challenges,” with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine. The webinar is part of PGTME’s fifth annual Lunchtime Lecture Series.

December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.

December 12, 9 – 11:30 am ET: Meeting of the Bioethics Collaborative. Topic: Is it Time to Retire the Concept of Deidentification?


September 2024: Barbara Bierer, Sylvia Baedorf Kassis and Alyssa Panton co-authored an article with Devaki Thavarajah and Trishna Bharadia entitled, “Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age,” published in Medical Writing.

The article discusses the importance of creating educational materials to improve public understanding of clinical research data, particularly in light of misinformation during the COVID-19 pandemic. It emphasizes the need for transparency and clarity in addressing issues like data privacy and the ethical sharing of information. Modern tools such as videos and infographics can make clinical research more accessible and build trust with patients and the public. 

October 19: Barbara Bierer authored a viewpoint article, “Declaration of Helsinki – Revisions for the 21st Century,” in JAMA.

The article addresses the significant updates to the recent 2024 revision of the Declaration of Helsinki, now celebrating its 60th anniversary. It highlights the expansion of ethical responsibilities to all researchers, the shift from “subject” to “participant” to emphasize autonomy, and the importance of “free and informed consent.” Additionally, it discusses complex ethical issues like vulnerability, inclusivity, post-trial access, and use of data for research. It also addresses the complexity of ethical issues in multi-national clinical research.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

September 2024 Newsletter

In the Spotlight

Mark your calendar for November 13-15, 2024, to attend a compelling three-day symposium featuring dynamic presentations and discussions. The first day is open to Executive and Steering Committee (EC/SC) sponsors. The annual two-day event that follows is open to all registrants at no cost. While we encourage in-person attendance, virtual participation is welcome.

Wednesday, November 13 – open to EC/SC sponsors: The day will begin with a meeting with the Post-Trial Responsibilities – Continued Access to Investigational Products working group, followed by lunch and the EC/SC meeting.

Thursday, November 14 – open to the public at no charge:

The day will feature a keynote address by Dr. Khair ElZarrad, Director of the Office of Medical Policy at the FDA, as well as presentations on the MRCT Center’s recent and upcoming work, breakout sessions, and a cocktail reception. Panel discussions will include AI – Synthetic Data and Digital Twins; Post-trial, Continued Access to Investigational Medicines and Devices; and Impacts of Revisions to the Declaration of Helsinki.

Friday, November 15 – open to the public at no charge: Vivli, the Center for Global Clinical Research Data, in conjunction with the MRCT Center, will host “Innovations in Data Sharing,” a half-day program featuring Dr. Steffen Thirstrup from the European Medicines Agency (EMA).

Click the link below to learn more about the agenda and to register for some or all events.


Upcoming Events: Health Literacy Month Webinar Series

Join us for three engaging and informative webinars to celebrate Health Literacy Month. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.  We encourage you to join all three sessions! You can register for each webinar below.

October 10, 12 – 1 pm ET: Session 1: Designing Impactful Informed Consent Processes that Empower Participants 

October 17, 12 – 1 pm ETSession 2: Creating and Sharing Plain Language Summaries: One Team’s Experience  

October 22, 12 -1 pm ETSession 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 


The Clinical Research Glossary: Now Expanded to 187 Words

The MRCT Center’s Clinical Research Glossary plays a vital role in promoting health literacy by providing clear and accessible definitions of complex research terms. This resource empowers all research participants, patients, and the broader public to make informed decisions about their involvement in clinical research. It ensures that everyone, regardless of background, can grasp critical concepts, ask informed questions, and fully engage in the research process.

Additionally, research professionals can use the glossary to communicate complex ideas in plain language, helping participants better understand study objectives, procedures, and risks and supporting meaningful dialogue.

In collaboration with CDISC, we added twenty new terms based on valuable input from the clinical research community. The newly expanded Clinical Research Glossary now includes 187 research terms, definitions, images, and related content, and is freely accessible under the terms of our Creative Commons license. We’ve also updated the Frequently Asked Questions section, including a Summary of Changes.

We encourage you to explore this vital resource, download it, and share the glossary within your networks.

If you’d like to suggest new terms or provide feedback, please use this form.


Join Us: December Biannual Meeting of the Joint Task Force for Clinical Trial Competency

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

The public is invited to attend virtual biannual meetings. The next meeting is December 10 from 9 – 11 AM ET. Proposed updates include Delphi results from the data management task force, the launch of a patient-centric competencies task force, proposed team science competencies, the Portuguese translation, application of the results from the JTF competency survey in the Philippines, and training community workers using the JTF framework.

Click here to register.


Mansfield-PhRMA Research Scholars at MRCT Center

On September 16, eight scientists and clinical researchers from hospitals and universities across Japan, three government officials from PMDA, AMED, and METI, and three staff members from the Maureen and Mike Mansfield Foundation in Washington, DC, visited the MRCT Center. Sarah White presented about the work of the MRCT Center, and Rebecca Li presented about Vivli and engaged in discussions with the scholars.


From September 14-21, Barbara Bierer attended the semi-annual meetings of the Technical Coordinating Committee and the Advisory Committee of the African Vaccine Regulatory Forum (AVAREF). In addition and in collaboration with WHO, she hosted a multi-day ethics training for national ethics committee members and chairs across Africa.


September 23: Carolyn Chapman served on a panel on Community Engagement and Accessibility at the Rosamund Stone Zander Translational Neuroscience Center (RSZ TNC) at Boston Children’s Hospital’s fifth research symposium entitled Paving the Path: Therapeutic Development Readiness for Rare Neurogenetic Disorders.

September 29-30: Sylvia Baedorf Kassis spoke at the Society for Clinical Data Management (SCDM) conference in Boston. On Sunday, September 29, she presented at the SCDM Leadership Forum, discussing how industry leaders can collaborate to simplify the clinical trial journey for patients and sites. On Monday, September 30, she participated in a panel focused on incorporating site and patient voices in decentralizing clinical trial activities. For both sessions, she was joined by Marilyn Neault, PhD, a Patient Advocate for Research and long-time co-leader of the MRCT Center Clinical Research Glossary workgroup.

October 8: Carolyn Chapman will present on the “Protection of Human Research Participants” at the American Association for Cancer Research (AACR)’s workshop on Translational Cancer Research for Basic Scientists.

October 8, 12:00 pm ET: Willyanne DeCormier Plosky will present with Zary Amirhosseini (Program Manager, MGH Disability Program), Martha Jones (Vice President, MGB Human Research Affairs), and Jeanhee Chung (Principal Investigator, MGH Lab of Computer Science; Instructor in Medicine, Harvard Medical School) on “Empowering Voices: Strategies for Involving Individuals with Disabilities in Research.” This webinar is part of the Chester Pierce Research Society Speaker Series.

October 8: Hayat Ahmed will participate in a Clinical Trial Diversity Roundtable hosted by Congresswoman Robin Kelly (IL), Chairwoman of the Congressional Black Caucus (CBC) Health Braintrust, at the La Rabida Children’s Hospital in Chicago.

October 10, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 1: Session 1: Designing Impactful Informed Consent Processes that Empower Participants 

October 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: 1) Laboratory Developed Testsand 2) Limitations on Sharing Data with China and Other Countries of Concern

October 10, 8 am – 4:30 pm ET: Dr. Barbara Bierer and Mark Barnes will be featured as panelists at the “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” a hybrid event hosted by the Department of Medical Ethics & Health Policy and the Institute for Translational Medicine & Therapeutics: University of Pennsylvania Perelman School of Medicine.

October 15, 12:00 pm ET: Willyanne DeCormier Plosky will present at the SCRS IncluDE Site Summit follow-up webinar titled “IncluDE Encore: Inclusivity Forum for People with Disabilities.”

October 17, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience

October 21, 11:00 am ET: Willyanne DeCormier Plosky will present at Penn State College of Medicine/ Penn State Clinical & Translational Science Institute on “Mapping the Participant Journey: Disability Inclusion in the Research Process.”

October 22, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 

Oct 31-Nov 1: Willyanne DeCormier Plosky will deliver a keynote speech at the University of Monterrey (Mexico) 2nd International Symposium on Medical Education. The keynote title is “Gender Perspectives and Inclusion: Key Elements in Transforming Medical Education for a Future of Personalized and Safe Care.”

Nov 13 – 15: MRCT Center Annual Symposium. Click here to learn more about the agenda and to register.

November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Keynote with Dr. Steffen Thirstrup of the European Medical Association (EMA). Click here to register for this event solely or for all MRCT Center Annual Symposium events.

The MRCT Center at PRIM&R Annual Conference:

  • November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Michelle Feige (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) will present “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
  • November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) will present “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?”
  • November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will join Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.”
  • November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) will present “Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.”
  • November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky will be presenting with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “(E01) Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
  • November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will moderate a panel titled “(H07) Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel will feature Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.

December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.

December 12: Meeting of the Bioethics Collaborative.


August 30: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.

September 25: The MRCT Center commented on the FDA Draft Guidance on Diversity Action Plans (DAPs) to improve Enrollment of Participants from Underrepresented populations in Clinical Studies (ID FDA-2021-D-0789-0111). The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA uses to assess the community engagement, site selection, recruitment, enrollment, and retention plans in DAPs (both for domestic and global trials). We also recommend clarifying whether DAPs are required for Phase 3 trials for both new and previously approved products, how to operationalize a “do no harm” approach in enrollment goals (that may involve global trial participants), and when it may be appropriate to disaggregate US enrollment goals/data from global enrollment goals/data. The comments suggest a framework similar to the April 2022 draft to improve the final guidance, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.


Ava Glazier, a student researcher at the MRCT Center since 2019, was recently promoted to Research Assistant.

Ava is involved in projects focused on Diversity, Inclusion, and Equity in Clinical Research, Cell and Gene Therapy, and Reproductive Health. Previously, she worked on initiatives related to pediatric populations in clinical trials, health literacy, and informed consent forms. In addition to her work at the MRCT Center, Ava has interned at Takeda Pharmaceuticals in the Health Equity Department and at FTI Consulting, where she contributed to efforts to increase patient access in large hospital systems. She is passionate about improving maternal health outcomes in underserved populations and advancing policies to enhance the healthcare experience for patients and providers.

Ava graduated from Brown University with a Bachelor of Arts in Public Health in May 2024. She is pursuing a Master of Public Health focusing on health policy at the Brown University School of Public Health.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

July/August 2024 Newsletter

In the Spotlight

Mark your calendar for mid-November to attend a dynamic three-day symposium featuring presentations and discussions with thought leaders and research stakeholders. The first day is open to Executive and Steering Committee (EC/SC) sponsors. The annual two-day event that follows is open to all registrants at no cost. While we encourage in-person attendance, virtual participation is welcome.

Wednesday, November 13: The day will begin with a meeting with the Post-trial, Continued Access to Investigational Medicines in Lower and Middle-Income Countries working group, followed by lunch and the EC/SC meeting.

Thursday, November 14: The day will kick off with a keynote address (TBA) and continue with presentations on the MRCT Center’s recent and upcoming work, breakout sessions, and a cocktail reception. A more detailed agenda will be released in our September newsletter.

Friday, November 15: Vivli, the Center for Global Clinical Research Data, in conjunction with the MRCT Center, will host “Innovations in Data Sharing,” a half-day program featuring Dr. Steffen Thirstrup from the European Medicines Agency (EMA).

A link to the registration will be emailed separately in the next two weeks.


Global Representation in Clinical Trials: New Resources

We are thrilled to unveil a suite of new resources aimed at advancing representation in global clinical trials: 

  • Model Diversity Action Plan (DAP): This tool, developed in response to the FDA’s latest draft guidance, is designed to improve diverse participant enrollment in clinical trials. It provides clear objectives and strategies for proactive recruitment, supporting alignment with FDA guidelines. The Model DAP builds upon these guidelines by emphasizing a broader international viewpoint and providing an appendix with detailed implementation suggestions. 
  • Global Diversity, Equity, and Inclusion (GDEI) Roadmap: This comprehensive guide offers insights into and addresses DEI across trials that involve sites outside of the US. It emphasizes the organizational preparation needed long before writing study diversity action plans, considerations of country regulatory and research priorities, and fair trial participation and access to tested products. 

We encourage you to investigate these new tools and listen to our podcast episode. Additional ethics and capacity-building tools, part of our Global Representation toolkit, are forthcoming.


Upcoming Events: Health Literacy Month Webinar Series

To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.  We encourage you to join all three sessions! You can register for each webinar below.

Session 1: Designing Impactful Informed Consent Processes that Empower Participants 

Thursday, October 10, 12 – 1 PM ET 

This webinar will feature the HHS Office of Human Research Protections, the NIH All of Us Research Program, and the MRCT Center, highlighting resources for communicating informed consent information in innovative, participant-centered ways.


Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience  

Thursday, October 17, 12 – 1 PM ET  

This MRCT Center webinar will feature experts from the Dana-Farber Cancer Institute who will share their return of results process for developing and making Plain Language Summaries available to participants in breast cancer-related studies driven by patient-advocates. 

Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 

Tuesday, October 22, 12 – 1 PM ET 

Spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham, the Research Ethics Action Collaborative for HRPPs (REACH) is an initiative designed to curate, align, and disseminate tools to advance representative inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.

Join the REACH collaborative webinar on improving PowerPoint presentations through clear, accessible, and inclusive methods. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how to apply accessibility tools to health literate communications. Because much communication is now virtual, we’ll explore how to make PowerPoint content readable and approachable, formatted for accessibility, and inclusive of people with disabilities.


On-Demand: Accessibility 101: How to Write Alt-Text and Map Participant Journeys

The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series in July, featuring two interactive exercises in which participants learned:

  • Basic information about disability statistics and disability rights, as shown through the Accessibility by Design (AbD) in the Clinical Research Toolkit, and different supports that you can readily implement.
  • How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
  • How to map the participant, family caregiver and/or supporter journey from different disability perspectives, from getting to/into the site location, navigating within the site to the other areas, and interacting with varying medical equipment and technology.

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

Updates: The meeting summary and slides from the June JTF Biannual Global Meeting Summary,  celebrating the 10th anniversary of the publication of the JTF Core Competency Framework, are now available. 

The JTF Framework has been translated into Portuguese, and is the twelfth translation now available. See the complete list here.


Contribute to Equitable Access: Share Your Experiences with Out-of-Pocket Costs in Clinical Trials

The MRCT Center is collaborating with the Equitable Access to Clinical Trials (EACT) project, hosted by the LUNGevity Foundation, to share best practices and promote financial neutrality for patients in clinical trials. The EACT project is developing a narrative document to demonstrate how extensively and in what contexts patients face out-of-pocket costs associated with medical care (e.g., labs, diagnostics, visits, medications) in clinical trials. If you have examples from your experience conducting cancer trials or as a cancer research participant, that you could share to inform this document, please go to the top of the EACT homepage and click on “SEEKING YOUR STORIES! TAKE OUR SURVEY.”  There is a template for responses and examples. Responses may be submitted anonymously.


Global CIMI Summit

In early July, the MRCT Center hosted the “Global CIM (Comprehensive and Integrative Medicine Summit 2024” at the Harvard Faculty Club in support of the ongoing collaboration with the Comprehensive and Integrative Medicine Institute (CIMI), Daegu Catholic University Medical Center (DCUMC), Dana-Farber Cancer Institute (DFCI) and other collaborators. Ten participants from South Korea–from CIMI, Daegu Catholic University School of Medicine, Daegu Haany University, and Chungang University School of Medicine– joined 14 U.S. collaborators from the MRCT Center, DFCI, Creighton University, Osher Center for Integrative Medicine, and others. This marks the 10-year anniversary of the CIMI/DCUMC collaboration with the MRCT Center. The summit was followed by a day of site visits (at MRCT Center, DFCI, and Osher Center) for the South Korean participants.


(Left to right: David Peloquin, Theresa Welch, Barbara Bierer, Mark Barnes)

Ropes & Gray Pro Bono Awards

The international law firm Ropes & Gray recently recognized the long-standing public health pro bono work of Mark Barnes. Mark Barnes co-founded the MRCT Center, and in his comments of appreciation, Mark credited several partners, including Barbara Bierer, his partner at Ropes & Gray and MRCT Center Senior Advisor David Peloquin, and his long-term assistant and friend Theresa Welch.


Left to right: Missy Heidelberg (Takeda Pharmaceuticals), Matt Rotelli (Eli Lilly and Co), Anna Kang (Genentech – a member of the Roche Group), Cris Woolston (Sanofi), Pat Nebel Hill (Genentech – a member of the Roche Group), CeCe Brotchie-Fine (Novartis), Karla Childers (Johnson & Johnson), Diana Pankevich (Pfizer), Barbara Bierer (MRCT Center)

August 15-16: Barbara Bierer attended the North American Regional Meeting on the Declaration of Helsinki (DoH) in Washington, DC, a meeting that was also attended by several MRCT Center Executive Committee and Steering Committee representatives. The meeting was the final discussion of the DoH revision. Dr. Bierer discussed the challenges in determining scientific and social value in clinical trials.  

August 24: Sylvia Baedorf Kassis was a featured speaker at the iCAN Virtual Chapter Meeting, sharing information on the Clinical Research Glossary and ways for young people to get involved.

August 30: Barbara Bierer presented on single IRB review of multi-site, multinational clinical trials at the international meeting entitled, “the U.S. single IRB policy: challenges and lessons,” hosted by the Pan American Health Organization (PAHO) Regional Program on Bioethics and Quality and Regulation of Medicines and Health Technologies Unit.


September 10: Meeting of the Bioethics Collaborative: Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research.

September 10: Sylvia Baedorf Kassis will present the Clinical Research Glossary at Pfizer’s internal Health Literacy & Patient Activation Community of Practice meeting.

September 29 – 30: Sylvia Baedorf Kassis will present two panels at the Society for Clinical Data Management (SCDM) conference in Boston. 

October 10, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 1: Designing Impactful Informed Consent Processes that Empower Participants

October 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: 1) Laboratory Developed Tests, and 2) Limitations on Sharing Data with China and Other Countries of Concern

October 10, 8 am – 4:30 pm ET: Dr. Barbara Bierer and Mark Barnes will be featured as panelists at the “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” a hybrid event hosted by the Department of Medical Ethics & Health Policy and the Institute for Translational Medicine & Therapeutics: University of Pennsylvania Perelman School of Medicine.

October 15, 12:00 pm ET: Willyanne DeCormier Plosky will present at the SCRS IncluDE Site Summit follow-up webinar titled “IncluDE Encore: Inclusivity Forum for People with Disabilities.”

October 17, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience

October 22, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 

Nov 13 – 15: MRCT Center Annual Symposium. A registration link will be sent separately soon.

November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Keynote with Dr. Steffen Thirstrup of the European Medical Association (EMA).


Stephen Sonstein and Barbara Bierer are co-authors of a Frontiers in Pharmacology editorial that introduces the collection of the Research Topic: “Building the Clinical Research Workforce: Challenges, Capacities and Competencies.” Thirteen articles discuss the challenges and opportunities relating to the clinical research workforce and highlight the role and significance of the Joint Task Force for Clinical Trial Competency (JTF) FrameworkFrontiers in Pharmacology has also published “Building the Clinical Research Workforce: Challenges, Capacities and Competencies” as an eBook.

Mariana Kruger, Moji Adeyeye, and Barbara Bierer co-authored a book chapter entitled “Pediatric drug development issues during public health emergencies” in the book Essentials of Translational Pediatric Drug Development. In their chapter, the authors outline the regulatory and ethical issues that arise during public health emergencies, focusing on pediatric drug development. 

July 15: The MRCT Center commented on the White House Office of Science and Technology Policy (OSTP) Request for Information entitled “Federal Evidence Agenda on Disability Equity,” published at 89 Fed. Reg. 46924 (May 30, 2024). Read more here

July 22: The MRCT Center commented on the National Institutes of Health (NIH) Office of Science Policy’s draft Intramural Research Program Policy: Promoting Equity Through Access Planning (NOT-OD-24-125). In brief, the MRCT Center recommended that NIH OSP (1) clarify and expand on the methods to promote equitable access, (2) consider greater flexibility in the application of this policy to investigational products, and (3) require direct engagement with community stakeholders and patient advocacy groups when NIH assesses the impact of the policy. Read more here.

August 1: Barbara Bierer authored an article, “The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research,” in the Journal of Bone and Joint Surgery.

August 5: Mark Barnes, colleagues at Ropes & Gray, and Barbara Bierer published “The PubPeer conundrum: Administrative challenges in research misconduct proceedings” in the journal Accountability In Research that analyzed the impact of PubPeer, an online platform that publicizes suspected data integrity concerns, on the research misconduct process and the institutional challenges of handling anonymous comments within current regulations. The authors propose processes to ensure that credible allegations are rigorously assessed while reducing the burden on institutions tasked with their investigation.

August 9: The MRCT Center commented on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with their communities prior to, during, and after research, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response.  Read more here.

August 19: The MRCT Center commented on the NIH Request for Information regarding its draft Public Access Policy (FR Doc. 2024-13373). We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences. Read more here.


Kaitlin Hersey joined the MRCT Center as a Project Coordinator in August 2024. With over a decade of diverse experience in biotech startup environments, nonprofit organizations, and executive support, Kaitlin brings her robust organization, document control, and operations experience to the Center’s administrative team. In her role, Kaitlin will leverage her understanding and passion for innovative, accessible healthcare to drive the center’s administrative and operational aspects forward.

Kaitlin holds an Associate of Science from Massachusetts Bay Community College and a Phi Theta Kappa Honor Society membership.


Mena Shaikh joined the MRCT Center as a Research Trainee/Student Intern in the summer of 2024. She works principally with Carolyn Chapman on the Cell and Gene Therapies project. She is interested in exploring the intersection of public health and clinical medicine and the epidemiology of noncommunicable diseases.

Mena received her BS in Biochemistry from Stony Brook University in 2021. She is currently pursuing her MPH in Epidemiology and Biostatistics from Boston University.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

June 2024 Newsletter

In the Spotlight

Please join the MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) for the first webinar in the Accessibility 101 series. People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning. This webinar will help advance that goal.

This webinar will feature two interactive exercises in which participants will learn:

  • Basic information about disability statistics and disability rights, as shown through the Accessibility by Design in Clinical Research Toolkit, and different types of support that you can readily implement.
  • How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
  • How to map the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.

More Information about REACH:

Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and

inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.

 Click here to learn more.


New Project Spotlight: Ethical Challenges in AI-Based Clinical Research

Recently, the MRCT Center, in collaboration with WCG Clinical, convened a task force to address ethical and regulatory challenges during the IRB review of clinical research protocols involving AI.

The task force includes diverse stakeholders from across the clinical research ecosystem, including representatives from academic medical centers and universities, biotechnology and pharmaceutical companies, AI technology researchers, and IRB ethicists, members, and chairs. This multidisciplinary group aims to shape guidelines and resources addressing the layered ethical and practical implications of applying AI in and to clinical research.

As AI continues to play an increasingly important role in society and clinical research, the task force will evaluate its use in various aspects of clinical trials, including protocol design, consent considerations, patient privacy and confidentiality, and participant recruitment. It will also evaluate AI when it is being studied as an investigational product for use in medical care. The task force aims to create guidelines and tools to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.

For more about this project, click here.


NOW OPEN through July 5: Public Review of the Clinical Research Glossary

The MRCT Center’s recently expanded Clinical Research Glossary has been developed with the input of an engaged stakeholder workgroup, including patients and participants, advocates, and clinical research professionals.

New words and definitions in the MRCT Center’s Clinical Research Glossary undergo a Public Review each year. This review allows anyone to provide feedback on existing terms and suggest new ones for consideration. Public Review ensures that the terms and definitions are a CDISC global standard.

We invite you to participate in this important process to refine and enhance this valuable resource, empowering participants with the health literacy tools they need to make informed decisions about their care.

Click here to learn more and contribute your feedback.

For more about the Clinical Research Glossary and how four organizations – Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation – are implementing it in participant communications, click here.


On-Demand: Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design

At a recent webinar, the MRCT Center released two new tools to the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit: the SOGI Data Collection Checklist and the SOGI Data Privacy Checklist.

Click here to view this on-demand webinar, download the slides, or access the extensive related resources list.


May 29-30: The MRCT Center External Advisory Board (EAB) held its ninth annual meeting on May 29. The EAB provided Center leadership input and perspective on select MRCT Center projects as well as an overarching strategy of the Center. The following day, May 30, the MRCT Center Executive Committee (EC) met to discuss emerging issues, the MRCT Center’s work in Africa, revisions to the Declaration of Helsinki, and upcoming meetings.  

June 4: “Action and Influence – Implementing the Clinical Research Glossary and Your Critical Role in Public Review” webinar. On-demand resources, including the recording and slides, are available here.

June 11: “Data Collection and Privacy: LGBTQIA+ Tools and Resources” webinar. On-demand resources, including the recording and slides, are available here.

July 10-11:  The MRCT Center will host the “Global CIM (Comprehensive and Integrative Medicine) Summit,” a program of the Comprehensive and Integrative Medicine Institute (CIMI) in South Korea. The meeting will feature discussions on planned research and outcomes and an update on the USA-Korea-China clinical research collaboration involving a three-country clinical trial.

July 22 – 26: Invited by and in collaboration with the African Vaccines Regulatory Forum (AVAREF), Barbara Bierer will be a member of a team traveling to Lusaka, Zambia, in late July to assess national regulatory and ethics committee processes. The mission is part of continent-wide capacity building in Africa.


May 31: Sylvia Baedorf Kassis and Barbara Bierer contributed to an article, “A Federally Qualified Health Center-led Ethics and Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs during COVID-19” in the Journal of Law, Medicine & Ethics.

COVID-19 illuminated the need for equity-informed practices in public health. This manuscript presents a community-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement between community health centers and the populations they serve.  

June 18: (NOT-OD-24-112). The MRCT Center submitted public comments on a proposed glossary of innovative clinical research terms published jointly by FDA and NIH, “FDA-NIH Terminology for Clinical Research.” We encouraged clarification of the scope and intended audience of the draft glossary and recommended additional terms for inclusion in the final version. The FDA-NIH glossary will complement the MRCT Center’s Clinical Research Glossary efforts.

June 18: Sylvia Baedorf Kassis contributed an article, “An Easy-to-Understand Clinical Research Glossary to Support Participants and Professionals,” to the Association of Clinical Research Professionals (ACRP) Blog.

June 20: Mark Barnes and Barbara Bierer published “Proposed Increases in Government Authority Over Research Misconduct Proceedings” in the American Medical Association’s JAMA Viewpoints.

The article examines a proposed increase in government authority over research misconduct proceedings and notes that academic and medical institutions should understand the public, political, and ethical pressures on the Office of Research Integrity (ORI) to enhance oversight of research integrity. Institutions can alleviate some of these pressures by making their research misconduct processes more exacting, efficient, and, when possible, more transparent regarding the outcomes of specific cases. This can lead to improved public trust in the scientific research enterprise.

June 20:  (FDA–2023–D–5470): FDA continued its guidance series on RWE, issuing “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” In support of the guidance, the MRCT Center submitted public comments requesting further development of FDA’s concerns that are unique to RWE-based studies and the cross-referencing of the current guidance to specific sections of other RWE guidance documents to streamline the end-user experience.

June 24: The MRCT Center submitted public comments in response to the World Medical Association’s (WMA’s) second phase of proposed revisions to the Declaration of Helsinki (DoH). Mark Barnes, MRCT Center Faculty Co-Director, attended the last working meeting on the DoH. In direct response to concerns discussed internally and with our Executive and Steering Committees, we recommended substantial revisions to the WMA Workgroup’s proposals, including recommending comments specific to vulnerable populations, research ethics committees, informed consent, and post-trial access. Both Mark Barnes and Barbara Bierer have been invited to attend the final WMA revision discussion meeting in Washington, D.C. this August.

June 24: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors of a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.

June 25: We responded to a series of three FDA draft guidance documents addressing eligibility criteria for U.S.-based cancer clinical trials. For all three documents, we were supportive of the efforts the FDA has taken to make clinical trials more representative of the intended post-approval patient population. We encouraged additional clarity and granularity with regard to operationalizing these draft guidelines, in advance of their final issuance. Further, we agreed that eligibility criteria should be carefully considered, caution against copying and pasting eligibility criteria from the protocol of one study into the draft protocol of a new study, and advocate that exclusion criteria should be clearly justified based on safety or ethical reasons.

(FDA-2024-D-1402) Specific to the first draft guidance of the series, (i) “Cancer Clinical Trial Eligibility Criteria: Laboratory Values,” we stated in our public comment submission that the MRCT Center agrees with the FDA that overly restrictive laboratory value-based eligibility criteria are problematic and that such criteria may well exclude the very cancer patients that may benefit from the treatment under study, particularly when the malignancy (or its prior treatment) is affecting those lab values. The MRCT Center also asked for more specific examples of how to describe the potential variation of lab values (e.g., by race) and any additional/confirmatory testing needed in the eligibility criteria so as to better support a position of inclusion-by-default and exclusion-only-when-necessary.

June 25: (FDA-2024-D-1377). The main takeaway from the public comments that we submitted on the second guidance in the series (ii) “Cancer Clinical Trial Eligibility Criteria: Performance Status is that we took a strong stance against using Performance Status as an eligibility criterion at all. The measures of performance status commonly used across cancer trial eligibility criteria, the Karnofsky Performance Status Score  (first developed in 1948) and ECOG Performance Status Scale (first developed in 1960), are outdated and highly subjective constructs. Their use as a proxy for disease progression in cancer trial eligibility criteria conflates illness with disability, and results in the discriminatory exclusion of many people with disabilities, which is counter to Section 504 of the Rehabilitation Act, Titles II or III of the Americans with Disabilities Act, and Section 1557 of the Affordable Care Act. We encourage FDA to adopt alternative measures that more appropriately reflect both the clinical risks (assessed by laboratory and diagnostic testing) and the individual participant’s experience and preferences.

June 25: (FDA-2024-D-1376). Our public comments on the third guidance (iii) “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications,” asked the FDA to clarify its use of the term “medication,” whether either the recommendations regarding concomitant medications or the washout period differ in the case of early (Phase 1/2a) versus late (Phase 3 and post-approval) trials, and when additional data and sub-studies might be needed to understand potential drug-drug interactions when participants are taking concomitant medications for chronic conditions.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

May 2024 Newsletter

In the Spotlight

AVAREF Advisory Committee

Barbara Bierer and Sarah White recently returned from a two-week work trip to Rwanda and Zimbabwe. The trip was motivated by the MRCT Center’s commitment to building clinical research capacity and a better understanding of local efforts to strengthen and sustain the clinical trial ecosystem. They first attended the African Vaccines Regulatory Forum (AVAREF) 14th Meeting of the Technical Coordinating Committee (TCC) and Steering Committee (SC) in Harare, Zimbabwe. The MRCT Center has partnered with AVAREF and, more broadly, with WHO for many years to build capacity for ethical review, optimize the integration of ethics review with regulatory processes, and strengthen the clinical trial ecosystem. To date, our work has included developing a fundamental research ethics training course (to be freely released in September 2024) and conducting site optimization visits to understand the challenges in clinical trial application reviews.

Dr. Bierer and Ms. White also spent time in Kigali, Rwanda, meeting with stakeholders, including the Rwanda FDA, Rwanda National Ethics Committee (RNEC), the University of Global Health Equity (UGHE), the UGHE Ethics Committee, the Butaro District Hospital, the Center for Family Health Research, and the Centre for Impact, Innovation, and Capacity Building for Health Information Systems and Nutrition (CIICHIN).

Working closely with the Bill and Melinda Gates Foundation and WHO, this trip provided significant insight into how the MRCT Center can collaborate with local stakeholders to improve the predictability, sustainability, and quality of clinical trials.

Click here to read more and view a slideshow of additional images.


How are people and organizations using the updated Clinical Research Glossary? Join us for an insightful webinar on Tuesday, June 4, from 11 – 12 PM ET to explore the practical uses and applications of the MRCT Center’s Clinical Research Glossary. Learn how this glossary can enhance the participant’s clinical research experience and how you can help shape the future of this resource, a resource recognized as a CDISC global standard.

Click here to register.

For more about the MRCT Center’s Clinical Research Glossary, including common questions, appropriate citation, and webinar recordings, click here.


Join us for a webinar on Sexual Orientation and Gender Identity (SOGI) Data in Clinical Research on Tuesday, June 11, from 12 – 1 PM ET. We will discuss key points from the SOGI Data Collection Checklist and SOGI Data Privacy Checklist, which will be released the same day, as part of the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit. The importance of representation, key points to consider, and implementation examples will be discussed. These tools build upon numerous efforts to develop guidance, test methodologies, and share lessons learned. Everyone should be able to see themselves in clinical research data and feel secure that their data is treated with respect and confidentiality.

Click here to register.

We look forward to sharing this important work with you.


The Multi-Regional Clinical Trials (MRCT) Center’s Joint Task Force for Clinical Trial Competency (JTF) is dedicated to enhancing standards and practices within the clinical research field. The JTF aims to foster a cohesive approach to advancing clinical research, ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically. More specifically:

Biannual Meeting Announcement

Please join us for our upcoming biannual meeting on June 6 from 9 – 11 AM ET. The agenda includes: 

We look forward to your participation and valuable contributions to these important discussions. 

Click here to register.


The MRCT Center has collaborated with a multistakeholder group on the Equitable Access to Clinical

Trials (EACT) project, hosted by LUNGevity Foundation, to share best practices and promote financial neutrality for patients in clinical trials.

Clinical trials are essential for developing new treatments but need more enrollment and participant diversity. Lower-income patients are especially underrepresented due to costs, with those earning less than $50,000 per year being nearly 30% less likely to join cancer trials. Participation can also financially burden caregivers.

Non-medical out-of-pocket costs include travel, meals, caregiving, and time away from work. Despite some sponsor support, these costs can still be barriers.

The EACT project offers resources to reduce financial burdens:

  • Best practice considerations and recommendations guide for sponsors
  • Tools for trial site personnel to assist in conversations with sponsors and patients
  • Patient needs assessment checklist for identifying non-medical financial needs
  • Policy recommendations to address tax and legal issues hindering financial support

The EACT project was recently profiled in STAT News. Click here to read the article.


On May 20, Clinical Trials Day, the National Academies of Sciences, Engineering, and Medicine (NASEM) hosted a hybrid public workshop of the Diversity Convergence Project, focused on building strategies for equitable participation, innovative trial design, and fostering community investment, engagement, and workforce development.

The need to improve diversity in clinical trials has been evident for many years, but a multi-sector action plan for system-wide, sustainable change was lacking. This critical work, initiated in June 2023 and led jointly by the MRCT Center, the Clinical Trials Transformation Initiative (CTTI)Milken Institute’s FasterCures, and the National Academies Forum on Drug Discovery, Development, and Translation, culminated in the recent release of the Toward A National Action Plan for Achieving Diversity in Clinical Trials framework. The plan, which outlines eight domains and actionable steps to drive system-wide collective action, aims to significantly increase the diversity of participants in clinical trials across the United States. This foundational framework document is a call to collective action. It has been (and continues to be) informed by the shared wisdom of hundreds of leaders in health equity and representation involved in a series of convenings over the last year.  

May 1: Barbara Bierer presented at Health Resources in Action (HRA)’s “Promoting Diversity in Clinical Trials” webinar, addressing the levers funders can use to advance representation in clinical trials and examples of guidance that funders can provide applicants.

May 3 – 15: Barbara Bierer and Sarah White traveled to Zimbabwe and Rwanda to better understand local efforts to strengthen and sustain the clinical trial ecosystem to support the MRCT Center’s commitment to building clinical research capacity. See the Spotlight above.

May 8: Carolyn Chapman presented a poster, “Delivering on the Ethics of Gene Therapy Trials,” at the American Society of Gene and Cell Therapy (ASGCT) annual convention. 

May 14: Sylvia Baedorf Kassis presented at the Institution for Healthcare Advancement’s annual Health Literacy Conference on “Meaningful Participant Engagement: Strategies to Include Diverse Perspectives from Program Development through Implementation.”  

May 16: Sylvia Baedorf Kassis moderated an expert panel and was featured as a speaker at Citeline’s TrialScope EXTRA event focused on trial transparency and disclosure processes.

May 20: Barbara Bierer presented “Diversity Convergence Project: Toward a National Action Plan for Achieving Diversity in Clinical Trials” at the National Academies of Science, Engineering, and Medicine. See above.

May 23 – 25: AAHRPP Annual Conference

  • May 22: Barbara Bierer co-presented with Anne Le Goff and Arash Naeim on “Safeguarding Participants in Emerging Technologies: Ethical Considerations in Clinical Trials.”
  • May 23: Barbara Bierer co-presented with Megan Kasimatis Singleton on “Has the Short Form Lost its Place in Research Consenting?”
  • May 23: Willyanne DeCormier Plosky presented with Katherine McDonaly on a panel entitled “Engaging People with Disabilities in Clinical Research Planning, Conduct, and Review.”
  • May 23: Barbara Bierer co-presented with Martha Jones on “Enhancing Justice and Access: DEI Resources, Tools, and Recommendations for IRBs and HRPPs.”
  • May 23: Lisa Koppelman co-led a session entitled “Including Young People in Research: How to Walk the Walk” with Dr. Gianna McMillan.

May 28: Dr. Barbara Bierer presented “The clinical trial ecosystem, IRB, investigators, health systems and regulatory authority–roles and responsibilities, and requirements” at the joint US FDA and Costa Rica symposium: Clinical Trials and Operational Considerations.

May 29-30: Meeting of the MRCT Center’s External Advisory Board and the Executive Committee.

June 4, 11 AM- 12 PM ET: “Action and Influence – Implementing the Clinical Research Glossary and Your Critical Role in Public Review” webinar. See Spotlight above.

June 11, 12 – 1 PM ET: “Data Collection and Privacy: LGBTQIA+ Tools and Resources” webinar. See Spotlight above.

logo

June 18, 9:30 AM – 12 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Reciprocity in Research: What do we owe host communities? Open to sponsors of the Bioethics Collaborative.


April 29: The MRCT Center submitted public comments to the FDA on collecting race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products.

Summary:

(FDA-2016-D-3561) The FDA will update this draft guidance document to align with new requirements published by the Office of Management and Budget. In the MRCT Center response, we (i) requested clarification on FDA’s expectations for how sponsors will use race and ethnicity data in shaping their clinical research endeavors; (ii) encouraged FDA to recommend the collection of geographic heritage as well as genetic ancestry; (iii) recommended FDA include specific guidance on whether and how such data may serve as Real World Data in support of regulatory submissions; and (iv) urged FDA to consider taking additional steps to ensure clinical trial representativeness.

April 30: The MRCT Center submitted public comments to the FDA on key information and facilitating understanding in informed consent: guidance for sponsors, investigators, and Institutional Review Boards.

Summary:

(FDA-2022-D-2997) The MRCT Center was encouraged by the FDA’s efforts to harmonize the informed consent regulations and guidance with the regulations and guidance of the federal Office for Human Research Protections (OHRP), the flexibilities incorporated into the guidance regarding informed consent forms (ICFs), and FDA’s emphasis on employing plain language throughout the informed consent process. We did offer suggestions for strengthening the guidance and specific comments on aspects of both the main text of the guidance and the hypothetical models included in the appendix. The Regulatory Affairs Professionals Society highlighted these comments after the comment period closed.

May 8: Katharine Wright, Willyanne DeCormier Plosky, Hayat Ahmed, Sarah White, and Barbara Bierer published “First, Do No Harm: A Global Perspective on Diversity and Inclusion in Clinical Trials” in Nature Reviews Drug Discovery.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

April 2024 Newsletter

In the Spotlight

The need for participant diversity in clinical trials is well-recognized, but the inclusion of LGBTQIA+ individuals has often been overlooked. The MRCT Center established a working group comprised of experts from medical and research institutions, pharmaceutical companies, CROs, clinics, advocacy groups, and LGBTQIA+ community members to improve engagement and participation. The working group aims to advance a more comprehensive integration of inclusivity in clinical research, particularly addressing the historical underrepresentation of LGBTQIA+ individuals.  

The MRCT Center has developed two practical guides – the LGBTQIA+ Inclusive Imagery Case Study and an LGBTQIA+ Inclusive Language Checklist – to assist researchers in effectively including LGBTQIA+ individuals in clinical trials to ensure that study populations are truly representative.  

Additional tools will be released throughout the year, and they will address data collection, privacy, and accountability. These are part of a comprehensive effort to ensure that all potential participants, including the LGBTQIA+ community, see themselves reflected in clinical trial research and outcomes. 

Please contact us here if you would like additional information or periodic updates about this work.


Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes.

The Diversity Convergence Project has convened several meetings over the last year to explore opportunities to improve racial and ethnic diversity in clinical trials, focusing on system-level change and collective efforts across organizations and sectors. The Clinical Trials Transformation Initiative (CTTI) hosted the first meeting in June 2023, the MRCT Center the second meeting in September 2023, and FasterCures and the Milken Institute the third meeting in November 2023.

The National Academies of Sciences, Engineering, and Medicine Forum on Drug Discovery, Development, and Translation and the National Cancer Policy Forum will host the fourth hybrid public workshop meeting on May 20 (Clinical Trials Day). This workshop will consider strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development. Based on input from the first three meetings, survey results, and analyses of existing research, a National Action Plan for Achieving Diversity in Clinical Trials will be released in advance of the May 20 workshop to facilitate collective action toward a framework for implementation.

Click here to register for the May 20 hybrid public workshop.


How are people and organizations using the updated Clinical Research Glossary? Join us for an insightful webinar on Tuesday, June 4, from 11 – 12 PM ET to explore the practical uses and applications of the MRCT Center’s Clinical Research Glossary. Learn how this glossary can enhance the participant’s clinical research experience and how you can help shape the future of this resource, recognized as a CDISC global standard.

Topics:

  • The Importance of Plain Language: Exploring how clear communication resources enhance understanding and trust-building.
  • Real-World Applications: Discussing case studies where the glossary has been implemented.
  • Public Participation in Public Review: Inviting feedback on proposed and existing glossary terms throughout the annual review cycle.

Click here to register.

For more about the MRCT Center’s Clinical Research Glossary, including common questions, how to cite the MRCT Center when using glossary resources in your materials, and resources, including slides and the recording from a recent webinar, click here.

JTF Framework: Now available in Arabic

The Arabic translation of the JTF Framework has been released. Click here to view.

The JTF Framework is now available in 11 languages: English, Spanish, Japanese, French, Thai, Bahasa Indonesia, Italian, Vietnamese, Chinese, Korean and Arabic. Click here for links to the complete list of translations.

Joint Task Force for Clinical Trial Competency (JTF) Global Meeting: June 6 

Please join us on Thursday, June 6, from 9 – 11:00 AM ET for the virtual biannual global Joint Task Force for Clinical Trial Competency (JTF) meeting to learn about updates and coordinate ongoing activities. We will hear about Cantrain, a comprehensive training program in Canada based in part on the JTF Framework, and other updates. This meeting is open to the public.

Click here to register.


Events & Presentations

April 2: The MRCT Center held a webinar to announce the release of the new, expanded Clinical Research Glossary. With over 160 definitions, including images and supportive information, the Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding. It is now a CDISC standard.

April 4-5: Barbara Bierer gave the keynote presentation “Decentralized Clinical Trials – An Evolving Landscape” at the Decentralized Clinical Trial’s two-day in-person workshop hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA. She also gave a presentation on “Ethics Review of Decentralized Clinical Trials.”

April 9: Willyanne DeCormier Plosky participated in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit: a plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research” and a breakout session entitled “Inclusivity Forum: People with Disabilities.” 

May 1: Barbara Bierer will present at Health Resources in Action (HRA)’s “Promoting Diversity in Clinical Trials” webinar, addressing the levers funders can use to advance representation in clinical trials and examples of guidance that funders can provide applicants.

May 3, 1:30-4 PM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Real World Evidence (RWE) and Emerging Trends in Clinical Trial Subject Recruitment. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).

May 8: Carolyn Chapman will present a poster, “Delivering on the Ethics of Gene Therapy Trials,” at the ASGCT Annual Meeting in Baltimore. 

May 7-10: Barbara Bierer and Sarah White will attend the AVAREF Technical Committee and Steering Committee meetings in Harare, Zimbabwe. They will present a summary of the work in Africa in which the MRCT Center has participated and discuss progress on training assets in development.

May 13: Barbara Bierer and Sarah White will engage bioethicists and ethics committee members in a robust discussion of challenges in Butaro, Rwanda.

June 14, 12:30 – 3 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Reciprocity in Research: What do we owe host communities? Open to sponsors of the Bioethics Collaborative.


March 30: The MRCT Center submitted a public response to the French National Institute of Health and Medical Research (“INSERM”)’s draft ethics charter aimed at the protection of healthy volunteers in clinical trials. The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered both a general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. While the MRCT Center’s comments reflected our support for the broader endeavor, a number of suggestions were made to more clearly define the intent and reach of the charter.

April 15: The MRCT Center submitted public comments to the FDA draft guidance on data monitoring committees in clinical trials (Docket #FDA-2001-D-0219).


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

March 2024 Newsletter

In the Spotlight

Please join us on Tuesday, April 2, from 12 – 1 PM ET to celebrate the MRCT Center’s newly expanded Clinical Research Glossary.

This plain-language global standard has been developed in collaboration with CDISC to benefit research participants and anyone interested in developing easy-to-understand research materials.

With over 160 definitions, including images and supportive information, the MRCT Center’s Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding.

Learn more about:

  • Building trust and transparency with participants through plain language information sharing.
  • The dedicated team members and robust process that is followed to create this global standard.
  • Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials. 

We look forward to sharing this important expanded resource with you.

Click here to register.


Please join us on Thursday, June 6, from 9 – 11:00 AM ET for the virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF). We will hear about a comprehensive training program in Canada based on the JTF Framework, coordinate ongoing activities, and review updates.

Please register here. 


As part of a recent update, we implemented a new Accessibility widget that allows users to access our website in over 50 languages and modify the user experience for many accessibility profiles. Explore this functionality by clicking on the Accessibility Menu icon on any page of the MRCT Center website.

We continue to add downloadable PDF translations of many of our resources, too, including the JTF Framework, now available in 10 languages here, and several pediatric informational brochures, available in Arabic and Urdu, as well as other languages.


Events & Presentations

March 7: The MRCT Center held a webinar to introduce the Research Ethics Action Collaborative for HRPPs (REACH) project, an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants—tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. Hayat Ahmed organized the webinar, and Barbara Bierer (MRCT Center), Ivy R. Tillman (PRIM&R), Michelle Feige (AAHRPP), and Martha F. Jones (MGB) presented. Webinar assets are available here, including the recording, slides, list of resources, Q&A, and a survey.

March 12: Barbara Bierer presented on the limitations of, and possible solutions to, regulatory pathways that involve non-life-threatening research in which consent is not feasible. Neither the FDA nor HHS has a readily available path to permit clinical research in settings that do not fit the specified exceptions from informed consent (EFIC) guidance (e.g., emergent settings in which consent is not possible but the condition is not life-threatening and available treatments are unproven or unsatisfactory). The conference, convened by the National Institutes of Neurological Diseases and Stroke (NINDS), NIH, explored the necessary components and guardrails that would allow this necessary research to proceed.

March 13: Barbara Bierer moderated a compelling session at DIA Europe 2024 entitled “Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review.” She was joined by colleagues Sneha Dave (Generation Patient, USA), Christina Bucci-Rechtweg (Novartis, USA), Siri Wang (Norwegian Medical Products Agency, Norway), and Dominik Karres (European Medicines Agency, The Netherlands) in a discussion that highlighted the importance—and challenges—of ensuring access of safe and effective medicines to children.  

March 22: Dr. Willyanne DeCormier Plosky conducted a training on the Inclusion of People with Disabilities in Clinical Research with Fellows from the Leadership Education in Neurodevelopmental and Related Disabilities (The LEND program) at Boston Children’s Hospital Institute for Community Inclusion. 

March 28: Sylvia Baedorf Kassis was a panelist for TransCelerate’s Enabling Individual Participant Data Return (iPDR): An Overview of TransCelerate’s Individual Participant Data Return Package webinar, where attendees learned about general considerations to enable data return to clinical study participants. 

March 28: Barbara Bierer was a panelist at the “Fostering Collaboration to Advance Representation Enrollment in Clinical Trials” webinar hosted by the Duke-Margolis Institute for Health Policy.

March 29: Dr. Barbara Bierer participated in a virtual roundtable co-hosted by FasterCures/Milken Institute, the Reagan Udall Foundation, the Clinical Trials Transformation Initiative, and the Foundation for NIH on “Imperatives for US Clinical Research Leadership and Coordination.” This virtual roundtable shared several initiatives underway across the government, private- and nonprofit sectors to build and coordinate clinical research infrastructure and capacity and to articulate and gain alignment around collective goals for the immediate term in 2024 while laying the groundwork for the future.

April 2, 12 – 1 PM ET: Clinical Research Glossary: New Words, New Opportunities webinar. (See Spotlight above). Click here to register.

April 4-5: Barbara Bierer will present at the Decentralized Clinical Trial’s two-day in-person workshop hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA.

  • April 4: Decentralized Clinical Trials: An Evolving Landscape Decentralized Clinical Trials: An Evolving Landscape will review the regulatory, ethical, and operational challenges in the planning and execution of such trials. The roles and responsibilities of PIs and other research and clinical team members will be discussed, as well as considerations for IRBs and institutional human research protection programs (HRPPs). 
  • April 5: Ethics Review of Decentralized Clinical Trials Dr. Bierer will review the ethical and regulatory responsibilities of sponsors, investigators, institutional review boards, and other stakeholders when planning and implementing DCTs. 

April 9: Dr. Willyanne DeCormier Plosky will participate in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit: a plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research” and a breakout session entitled “Inclusivity Forum: People with Disabilities.” 

April 11, 10 AM -2 PM (Closed Meeting). Barbara Bierer will discuss, “The Clinical Trial Ecosystem, IRB, Investigators, Health Systems and Regulatory Authority – Roles, Responsibilities, and Requirements” at the Clinical Trials & Operational Considerations and Excellence Workshop, a workshop aimed at deepening the understanding of the regulatory system for clinical trials in Costa Rica and the United States, and its global context, co-organized by the US FDA and Costa Rican Ministry of Health.

May 3, 1:30-4 PM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Real World Evidence (RWE) and Emerging Trends in Clinical Trial Subject Recruitment. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).


March 1: In an article, “Ethical Considerations in Decentralized Clinical Trials,” published in the Journal of Bioethical Inquiry, Barbara Bierer and Sarah White summarized salient ethical issues in the design and conduct of decentralized clinical trials, including participant safety, privacy and confidentiality, consent, digital access and proficiency, and trial oversight. Given the increasing involvement of decentralized study components, it is necessary to develop processes and cooperative solutions to promote safe, ethical trials, as well as focus on decreasing burden and increasing access for all participants.  

March 21: The MRCT Center submitted public comments to support the FDA’s draft guidance, “Master Protocols for Drug and Biological Product Development: Guidance for Industry,” and addressing several areas that could benefit from further clarification and guidance, highlighting the need for specificity in rare disease trials and informed consent practices.


We are thrilled to welcome four new Program Managers to our team:

Trevor Baker will be primarily involved in projects on Artificial Intelligence, Environmental Sustainability, and Platform Studies. 

Before joining the MRCT center, Trevor worked as a Research Project Manager at Boston Medical Center on a multi-regional trial in the research area of overdose prevention. 


Emina Berbic will be primarily involved in the Bioethics Collaborative, Cell and Gene Therapy, and Decentralized Clinical Trials projects.

Before joining the MRCT Center, Emina was a Project Manager at MGH, spearheading initiatives to innovate care for bipolar disorder. Her diverse background includes involvement in clinical trials within a global CRO and contributing as a graduate research assistant to the sidHARTe project, which concentrated on fortifying emergency health systems in emergency obstetric and neonatal care. Additionally, she contributed to a project addressing the double disease burden in Eswatini during her time at Columbia University.


Alex Marroquín joined the MRCT Center in March 2024 as a Program Manager. Alex is primarily involved in projects related to patient broad consent and Center communications.

Prior to joining the MRCT Center, Alex worked for Boston University/Boston Medical Center as a data analyst and research coordinator in sub-Saharan countries.


Emad Salman Shaikh will focus primarily on developing and designing a series of training modules. He is also collaborating on harmonizing efforts to build capacity for clinical research in new geographical regions.

Emad earned an MD from Pakistan and did his residency training in Orthopedics at the ACGME-I accredited Weil Cornell affiliated Hamad General Hospital in Doha, Qatar. He brings 15 years of experience in direct patient care, medical affairs, clinical trial operations, and management. Previously, he worked for Massachusetts General Hospital, among others. He has also contributed to designing studies, writing several articles, poster abstracts, book chapters, and quality improvement projects.


The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

February 2024 Newsletter

In the Spotlight

The MRCT Center, in collaboration with CDISC, presents the newly expanded and re-designed Clinical Research Glossary. With the dedicated efforts of numerous volunteers, content has been updated, and more than a hundred new terms have been added. Highlights include specialized information to help support participants and tailored, shareable images to foster engagement and understanding. Please join us on April 2, from 12 – 1 PM ET, to explore how this Clinical Research Glossary meets the needs of participants and the clinical research industry.

Click here to register.



REACHing Inclusion: Pioneering Pathways in HRPPs: March 7, 12 – 1 PM ET

Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham. This effort aims to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. 

Join us for an engaging webinar on Thursday, March 7, from 12 to 1:00 PM ET. This interactive session will explore actionable strategies to operationalize inclusion efforts in HRPPs, including (1) Making the Case for Leadership, (2) Establishing a Roadmap for Change, (3) Presenting Resources, and (4) Soliciting Examples.

We welcome your collaboration in this collective endeavor to strategize and operationalize efforts within IRBs and HRPPs.

Click here to register.


Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes.

The MRCT Center is collaborating on an initiative with the Clinical Trials Transformation Initiative (CTTI)FasterCures, and the National Academies of Sciences Engineering and Medicine (NASEM) to catalyze system-level change and collective efforts across organizations and sectors to achieve racial and ethnic diversity in U.S. interventional clinical trials.

As part of this collaborative endeavor, a series of meetings have been held, each hosted by one of the participating institutions.

The National Academies of Sciences, Engineering, and Medicine Forum on Drug Discovery, Development, and Translation and National Cancer Policy Forum will organize a hybrid public workshop on April 23, 2024, the last of the four convenings, to explore opportunities to improve racial and ethnic diversity in clinical trials with a focus on system-level change and collective efforts across organizations and sectors. This workshop will consider strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.

Click here to register.

Faculty Co-Directors Mark Barnes and Barbara Bierer and Executive Director Sarah White at the 2023 Annual Meeting

Proceedings from the MRCT Center Annual Meeting in December 2023 have been posted. The meeting included a keynote by Dr. Peter Arlett, Head of Data Analytics and Methods Task Force of the European Medicines Agency (EMA), and panel discussions on post-trial responsibilities/continued access to investigational products, an international framework for specimen sharing (the Seattle Principles), and diversity action plans and global considerations for clinical trials.  


Events & Presentations

February 12: Dr. Barbara Bierer virtually presented “The Principle of Justice in Human Participant Research” to the Neurosciences Clinical Trials Consortium. 

February 14: Barbara Bierer delivered the keynote address at the 2024 Clinical Trials Training Summit: Mastering Excellence through Innovative Competency Training, a meeting hosted by CANTRAIN, CAN-TAP-TALENT, StrokeCog and CBITN, in Montréal, Canada. Her presentation was entitled “From Theory to Practice: Development and Implementation of the JTF: Joint Task Force for Clinical Trial Competency Framework.”

February 15: Barbara Bierer presented the keynote lecture, “Striving for Sustained Change: The Principle of Justice in Human Participant Research,” at the University of North Carolina at Chapel Hill.

March 7, 12 – 1 PM ET: Representatives from the MRCT Center, Mass General Brigham, AAHRPP, and PRIM&R will discuss the Research Ethics Action Collaborative for HRPPs (REACH) initiative at a webinar. (See Spotlight above.) Click here to register. 

March 8, 11 AM – 2 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Advancing Inclusion: Integrating Pregnant and Lactating People in Research. Open to sponsors of the Bioethics Collaborative.

March 12, 8:30 AM – 4:30 PM (closed meeting): Barbara Bierer will present at the Regulatory Determinations related to Informed Consent, EFIC, and Waiver of Consent in Emergency Clinical Trials Workshop, hosted by NIH in Rockville, MD.

March 13, 10:50 AM- 12:00 Noon (16:50-18:00 CET): Barbara Bierer will moderate and present “Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review” at the DIA Europe 2024 in Brussels, Belgium.

March 22, 9 – 11:30 AM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Expanded Access (Compassionate Use) for Drugs and Devices. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).

March 22, 10 – 11 AM ET (closed meeting): Dr. Willyanne DeCormier Plosky will conduct a training, “Inclusion of People with Disabilities in Clinical Research,” with Fellows from the Leadership Education in Neurodevelopmental and Related Disabilities (LEND Boston) at Boston Children’s Hospital Institute for Community Inclusion. 

March 28, 9-10 AM ET: Sylvia Baedorf Kassis will be a panelist for TransCelerate’s “Enabling Individual Participant Data Return (iPDR): An Overview of TransCelerate’s Individual Participant Data Return Package” webinar, where attendees will learn about general considerations to enable data return to clinical study participants. 

March 28, 10 AM – 2:45 PM ET: Barbara Bierer will be a panelist at the “Fostering Collaboration to Advance Representation Enrollment in Clinical Trials” webinar hosted by the Duke-Margolis Institute for Health Policy.

April 2, 12 – 1 PM ETClinical Research Glossary: New Words, New Opportunities webinar. (See Spotlight above). Click here to register.

April 4-5: Barbara Bierer will present at the Decentralized Clinical Trials two-day in-person workshop, hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA.

April 9, Dr. Willyanne DeCormier Plosky will participate in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit:

·  9:00-9:30 AM ET: Plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research.”

·  10:30 – 11:30 AM ET: Breakout session titled “Inclusivity Forum: People with Disabilities.”  

April 11, 10 AM -2 PM (Closed Meeting). Barbara Bierer will discuss, “The Clinical Trial Ecosystem, IRB, Investigators, Health Systems and Regulatory Authority – Roles, Responsibilities, and Requirements” at the Clinical Trials & Operational Considerations and Excellence Workshop, a workshop aimed at deepening the understanding of the regulatory system for clinical trials in Costa Rica and the United States, and its global context, co-organized by the US FDA and Costa Rican Ministry of Health.


Publications

February 1: In collaboration with Barbara Bierer and others, MGB authors Francis Shen and Benjamin Silverman developed a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research. The article, Returning Individual Research Results from Digital Phenotyping in Psychiatry, was published in the American Journal of Bioethics.
 
February 8: The MRCT Center submitted public comments to the World Medical Association on the Declaration of Helsinki. The WMA’s Declaration of Helsinki is an often-referenced, foundational guidance document for the clinical research enterprise. The MRCT Center submitted targeted recommendations to the WMA on areas such as health literacy, accessibility, informed consent, participant autonomy, and post-trial responsibilities (among others) in the first of two public consultation periods. We await the second public consultation with interest.
 
February 12: The MRCT Center submitted comments in response to the Department of Justice (DOJ) Notice for Proposed Rulemaking (NPRM) request to revise the regulations implementing title II of the Americans with Disabilities Act (ADA), 28 CFR part 35, in the draft, “Nondiscrimination on the Basis of Disability; Accessibility of Medical Diagnostic Equipment of State and Local Government Entities.” 


New Executive Committee Sponsorship

The MRCT Center welcomes WCG, a leading global provider of ethical and regulatory approvals and compliance services for clinical research, focusing on improving the quality and efficiency of clinical trials, to the Executive Committee of the MRCT Center.



The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.