News

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.