News Type: Newsletter

In the Spotlight

New Tools to Support Global Representation in Research

We are excited to share two new documents to support Global Representation in Research:

Embedding Ethical Considerations Relating to Global Representation in Clinical Research delves into the ethical responsibilities of ensuring representative global participation in clinical trials. It addresses critical questions about who is included in the research, why they are included, and how the study can ensure that all participants benefit from the findings. It explores ethical implications for specific populations, particularly in low-resource settings, and presents frameworks to help sponsors address ethical concerns when designing and implementing clinical trials.

Working with Partner Countries to Strengthen Research Capacity Relating to Global Representation outlines the challenges and opportunities in strengthening research infrastructure, regulatory processes, and local expertise, particularly in low-resource settings. It offers insights into how supporting local researchers, institutions, and national environments can create sustainable, high-quality clinical research systems.

These materials complement the MRCT Center Global Representation Roadmap: Prompts for Developing a global diversity, equity, inclusion, and accessibility (DEI) strategy, Model Diversity Action Plan (DAP), and “Trials Beyond Borders” podcast series.

Webinar: A Shared Language for Clinical Research—How Technical Organizations Are Embracing Plain Language

Thoughtful, easy-to-understand scientific information benefits everyone – from patients and participants to researchers and industry professionals. Join us on May 8, 10–11 AM ET, to discuss how technical data sciences organizations are embracing patient-centricity and health literacy best practices by adopting the MRCT Center’s Clinical Research Glossary. Experts from the Society for Clinical Data Management (SCDM), Clinical Data Interchange Standards Consortium (CDISC), and the MRCT Center will share how their organizations integrate health literacy principles to improve understanding and engagement.

Events & Presentations

February 25: The MRCT Center, on behalf of the Convergence Project, hosted a webinar on “Opportunities to Engage and Retain Talent in the Clinical Research Workforce.” A high-level summary of the webinar is now available.

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

March 17: Willyanne DeCormier Plosky spoke on a panel, “Laying the Foundation for Effective and Equitable Representation in Clinical Trials,” at the Patients as Partners Conference in Boston, MA.

March 19: The MRCT Center and Vivli co-facilitated an invite-only forum, “From Policy to Practice: Implementing the European Health Data Space (EHDS) for Responsible Data Sharing.

March 21: Willyanne DeCormier Plosky led a training on “Accessibility by Design” for the Leadership Education in Neurodevelopmental and Disabilities (LEND) Fellows Program at Boston Children’s Hospital.

March 24: Sarah White participated on a panel, “Navigating the Shifting Landscape of Trial Placement and Site Selection for Globally Impactful Oncology Research,” at the Immuno-Oncology 360° (IO360°) program in Boston, MA.

March 27: Barbara Bierer spoke about the Declaration of Helsinki at the National Comprehensive Cancer Center (NCCN) IRB Directors Forum in Orlando, Florida.

April 2-3: Barbara Bierer will attend “the 2^nd WHO Global Clinical Trials Forum: Action for Impact” meeting in Geneva, Switzerland. The discussions will focus on advancing the WHA75.8 implementation globally and include a specific review of the Global Action Plan.

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

April 3, 10 – 11 AM ET: Data Literacy in Clinical Research: Enhancing Trust and Transparency. See Spotlight above.

April 8, 1:15-2:15 PM ET: Willyanne DeCormier Plosky will join fellow speakers Nonso Ezema (NexGen Research), Brittany Gerald-Lewis (Moderna), and Lisa Moneymaker (Medidata) and moderator Ashley Moultrie (Syneos Health) for a session titled “Cultural Sensitivities & Considerations” at the SCRS IncluDE Site Solutions Summit in Atlanta, GA.

April 9, 11:00 AM-12:00 PM: Willyanne DeCormier Plosky will speak with Elizabeth Johnson (University of Montana) at a panel titled “Distance as a Disparity in Oncology Outcomes,” moderated by Angel Akinbinu (Syneos Health) at the SCRS Oncology Site Solutions Summit in Atlanta, GA.

April 10, 1 – 3:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Congressional Investigations into Research Activities and Update on DOJ’s Restrictions on Sharing Bulk Sensitive Personal Data with China and other Countries of Concern. Click here to learn more about the Research, Development, and Regulatory Roundtable (R3)

April 24-27: Sylvia Baedorf Kassis will speak at the Association for Clinical Research Professionals Annual Conference in New Orleans, LA, presenting in two separate sessions focused on: 1) representation in clinical trials and 2) the integration of participant perspectives into clinical research materials.

May 6: 1 – 2 PM ET: Innovative Approaches to Gene Therapy Long-Term Follow-Up: Leveraging Registries and Platform Trials. See Spotlight above.

May 8: 10 – 11 AM ET: A Shared Language for Clinical Research: How Technical Organizations are Embracing Plain Language and Implementing the MRCT Center’s Clinical Research Glossary. See Spotlight above.

May 10-14: Sarah White and Barbara Bierer will attend the ICH Meetings in Madrid, Spain. During this time, Ms. White and Dr. Bierer will be meeting with the E6(R3) and M11 Expert Working Groups. 

Publications

February 24: The MRCT Center’s public comments on the FDA’s draft guidance, Considerations for Including Tissue Biopsies in Clinical Trials, FDA-2024-D-2402, recommend enhanced clarification on biopsy justification, prioritization of less invasive methods, consent specificity for future research, and strengthened IRB considerations to improve ethical rigor and participant protections.

March 11: The MRCT Center commented on the FDA’s draft guidance, Study of Sex Differences in the Clinical Evaluations of Medical Products, FDA-2024-D-4245, advocating for the use of real-world data (RWD) and real-world evidence (RWE) to support post-marketing evaluations of sex differences, inclusion of intersex and transgender individuals, additional guidance on the inclusion of pregnant and lactating individuals, and further advice on statistical approaches to detect sex-based differences.

March 11: Carolyn Chapman and co-authors’ Target Article, “Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?” was published in The American Journal of Bioethics and was accompanied by 15 Open Peer Commentaries and one Editorial. In March, AJOB published Dr. Chapman and colleagues’ reply to the commentaries entitled, “Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research,” emphasizing their goal to generate discussion about what, if anything, should be done ethically to manage the potential for group harm in data-centric research.

March 26: Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by Anna M. Anderson (University of Leeds), in Nature Medicine titled, “A global call to action for disability inclusion in health research.”

Disabled people are often excluded from health research despite being the largest underserved group in many countries, having worked to enshrine legal mandates for fair treatment and equal opportunity, and driving innovations that benefit everyone. The article describes the research cycle, points at which disabled people currently face barriers, and actions that can be taken by the research community to better involve disabled people during those points in the research cycle. This call to action is made by authors from different countries around the world as part of the Disability Inclusion in Research Collaboration (DIRECT) to emphasize the critical importance of collaboration, learning, and support across countries on this issue.

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.

In the Spotlight

Celebrating Dr. Bierer’s Leadership in Research Advocacy

Dr. 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 on March 12 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.

Events & Presentations

January 16: Barbara Bierer, MRCT Center Faculty Director, was an invited speaker and participant at the European Open Science Cloud (EOSC)-European Network of TRUSTed research environments workshop, hosted by ECRIN. She spoke on “Support of IPD meta-analyses through trusted research environments (TREs)” during the global webinar.

January-February 2025: Mark Barnes, MRCT Center Faculty Co-director and Partner, Ropes & Gray, Ropes & Gray colleagues, and Barbara Bierer, presented three webinars addressing early actions of the Trump administration that impact research:

• February 9: “NIH Caps Indirect Costs at Flat Rate: Critical Implications for Research Institutions
• January 29: “The Trump Administration’s DEI-Related Executive Orders: Implications for Federal Funding”
• February 5: “Pressures on Research Funding under the Trump Administration: Indirect Cost Recovery and other Restrictions”

February 12-13: Hosted by the WHO and ETH Zurich, Barbara Bierer joined colleagues in Zurich, Switzerland, for discussions about the ethics and operational challenges of clinical trials that include decentralized clinical trial elements. The two-day meeting was an initial exploration to inform the development of a future WHO framework and guidance on the topic.

February 19-20: Sylvia Baedorf Kassis presented at OHRP’s Research Community Forum, an in-person event hosted by the Augusta University Institutional Review Board in North Augusta, SC. Sylvia was a co-panelist discussing informed consent guidelines and regulations, and also led a session on designing consent processes with the participant in mind.

February 21: Sylvia Baedorf Kassis joined the Navigating IRB Community Engagement (NICE) team of the Augusta University Institutional Review Board to share and listen at an in-person community forum entitled “Looking Beyond Tuskegee” at the Lucy Craft Laney Museum of Black History.

February 24: Dr. Barbara Bierer presented the first address at Session #1: Setting the Scene of the Lysosomal Storage Disease Data Sharing webinar series, hosted by C-Path’s Critical Path for Lysosomal Diseases in collaboration with the Orphan Disease Center – University of Pennsylvania. She discussed key ethical considerations and policies that shape data sharing in rare disease research, highlighting best practices for responsible and effective data collaboration to advance scientific discovery.

February 25, 10 AM – 1 PM ET: Willyanne DeCormier Plosky, Hayat Ahmed, and Barbara Bierer joined Convergence Project colleagues to present Opportunities to Engage and Retain Talent in Clinical Research: Workforce Development, a workshop hosted by the MRCT Center.

March 5, 11 AM – 12 PM ET: The MRCT Center, in collaboration with the Equitable Access to Clinical Trials (EACT) initiative, hosted by LUNGevity Foundation, invites you to a webinar, Equitable Access to Clinical Trials: Best Practices for Industry. This session will explore best practices for financial support in clinical trials, practical strategies to reduce participant burden, and key considerations for sponsors and Clinical Research Organizations (CROs).

March 10: Meeting of the Bioethics Collaborative. Topic: Medical Need or Market Opportunity: Setting Research Priorities. Click here to learn more about the Bioethics Collaborative.

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. 

March 24: Sarah White will speak on a panel, “Navigating the Shifting Landscape of Trial Placement and Site Selection for Globally Impactful Oncology Research,” at the Immuno-Oncology 360° (IO360°) program in Boston, MA.

March 27, 11:15-11:45 AM ET: Barbara Bierer will speak on the Declaration of Helsinki at the National Comprehensive Cancer Center (NCCN) IRB Directors Forum in Orlando, Florida.

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

April 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Congressional Investigations into Research Activities and Update on DOJ’s Restrictions on Sharing Bulk Sensitive Personal Data with China and other Countries of Concern. Click here to learn more about the Research, Development, and Regulatory Roundtable (R3)

Publications

February 4: The MRCT Center submitted public comments in response to the FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification, such as the identification and validation of surrogate endpoints, the rigor and timeliness of confirmatory trials, expansion of public disclosures for regulatory actions, increased transparency regarding decision-making and withdrawal, and global considerations in the absence of international harmonization of these regulations.

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.

In the Spotlight

Reaffirming our Commitment to our Mission and Values

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.

Events & Presentations

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 ET: Opportunities 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

Publications

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.

MRCT Center Updates

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.

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. 
• A 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: 

• Investigational Medicines Framework
• Investigational Significant-Risk, Implantable Device Framework – to be released in 2025. 

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.

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.

Events & Presentations

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 14^th 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.

Publications

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.

MRCT Center Updates

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.

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.

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

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.

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.

Events & Presentations

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 Demand: Designing Impactful Informed Consent Processes that Empower Participants webinar.

October 17: Now On Demand: Creating 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?

Publications

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 21^st Century,” in JAMA.

The article addresses the significant updates to the recent 2024 revision of the Declaration of Helsinki, now celebrating its 60^th 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.

In the Spotlight

Join Us for the MRCT Center’s Annual Symposium in Boston!

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.

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.

Events & Presentations

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 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 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.

Publications

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.

MRCT Center Updates

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.

In the Spotlight

Join Us for the MRCT Center’s Annual Symposium in Boston!

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.

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 10^th 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.

Events & Presentations

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.

Upcoming Webinars and Presentations

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).

Publications

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) Framework. Frontiers 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.

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.

In the Spotlight

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

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.

Publications

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.

In the Spotlight

Strengthening and Sustaining the Clinical Trial Ecosystem in Africa

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.

Webinar: Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

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.

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.  

Publications

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.

In the Spotlight

LGBTQIA+ Resources

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.

Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

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.