In the Spotlight
“What’s Your Why?”- Amplifying Participant Voices in Clinical Trials Week
During Clinical Trials Week, the MRCT Center premiered a weeklong “What’s Your Why?” video series, featuring eleven patients, caregivers, and health professionals who shared the personal motivations that drive their commitment to research. From cancer survivors whose trial experiences became today’s standards of care to caregivers finding hope in each study visit, these firsthand stories exemplify why amplifying the voices and lived experiences of participants is vital: it ensures that trial design is ethical, practical, and truly centered on those it aims to serve. Watch the full series and learn more here.
Save the Date: MRCT Center Annual Symposium – Meeting the Moment
Wednesday, October 22 | Boston & Virtual
Join us for a full day of discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges. Engage with regulators, industry leaders, patient advocates, and research experts to gain privileged insights, shape the conversation, and forge connections that drive real-world impact. The symposium is free and open to all registrants.
On Thursday morning, October 23, join a co-branded program with Vivli on data sharing, privacy, and regulation (topic specifics TBA)—also complimentary and open to all Symposium registrants.
Register today to secure your spot and help drive responsible innovation in clinical trials.
New Podcast Episode: Trials Beyond Borders: Clinical Trials in Latin America—Aligning Global Research with Local Realities
Dr. Carla Saenz, Regional Advisor for Bioethics at the Pan American Health Organization (PAHO), speaks with Willyanne DeCormier Plosky, MRCT Center Program Director, to unpack the clinical trial landscape in Latin America.
They discuss:
- How demographics, healthcare infrastructure, and insurance models shape who can—and does—participate
- Ethical and regulatory strategies to broaden inclusion
- The influence of CIOMS and other international guidance on local trial ethics
- Designing global studies that honor regional contexts without sacrificing scientific rigor
This episode highlights the critical need for equitable access and culturally responsive research in today’s global trial environment.
For more about the MRCT Center’s work on Global Representation in Clinical Trials, click here.
Upcoming MRCT Center Webinars
June 2: Joint Task Force for Clinical Trial Competency (JTF) Biannual Meeting
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 outlines the competencies that professionals need to conduct clinical trials ethically and effectively.
Join the JTF Biannual Global Meeting on Monday, June 2, from 9:00 – 11:00 AM ET, to explore advances in clinical research workforce development and competency-based training, including:
- Integrating JTF Competencies: Curriculum Design and Accreditation at Arizona State University
- Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
- Results from a Delphi study on data management competencies
- Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
Registrants will receive slides and a meeting summary after the meeting.
June 24: Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process
Join us on Tuesday, June 24, from 12:00 – 1:00 PM ET to learn about the MRCT Center’s Clinical Research Glossary, a collaboratively developed plain language resource designed to enhance understanding of clinical research terminology. Learn how to participate in the annual Public Review (June 6 – July 6)—an essential step toward making these terms a CDISC global standard. Your involvement ensures the glossary remains accurate, inclusive, and effective for informed decision-making in clinical research.
June 24: A Framework for AI Adoption and Oversight in Clinical Research
Please join us on Tuesday, June 24, from 3:00 – 4:00 PM ET for a webinar to launch the MRCT Center and WCG’s Review Framework for Clinical Research Involving Artificial Intelligence (AI). This framework supports Institutional Review Boards (IRBs) in reviewing research where AI is a component of the research. The framework was developed through a multi-disciplinary task force, and these actionable tools offer both (1) structured guidance grounded in U.S. regulations and (2) ethical considerations to assist IRBs in evaluating benefits and risks while ensuring oversight and transparency across the AI development lifecycle. This session introduces a practical decision-making resource intended to help IRBs determine when and how to apply appropriate and proportionate oversight to protocols involving AI.
Key Topics:
- Introduction to the IRB review framework focusing on aligning review practices with existing regulations and ethical standards.
- Structured questions IRBs can use to assess risk, benefits, and ethical considerations when AI is used as a research intervention.
- An expert panel discussion on navigating ethical considerations during IRB review
June 26: Patient-Centered Approaches for Gene Therapy Long-Term Follow-Up
Please join us on Thursday, June 26, from 1:00 – 2:00 PM ET, for a webinar in which we will discuss patient-centered approaches in the specific context of Gene Therapy (GT) Long-Term Follow-Up (LTFU) studies.
GTs have the potential for long-lasting and transformative health benefits, but there are also possible long-term health risks. As LTFU studies can last years, they often pose significant burdens on patients and their caregivers. As a complement to our May 6 webinar, Innovative Approaches to Gene Therapy Long-Term Follow-Up – Leveraging Registries and Platform Trials, this webinar will consider patient needs and preferences in the design and conduct of LTFU for GTs. The convened panel will offer different perspectives on how we can put patients at the center of LTFU for GTs.
Events & Presentations
May 6: In the webinar “Innovative Approaches for Gene Therapy Long-Term Follow-Up,” panelists examined cutting-edge strategies, such as global registries and platform-trial master protocols, to tackle the scientific and logistical challenges of multi-decade safety monitoring. Moderated by Dr. Carolyn Riley Chapman, panelists from the World Federation of Hemophilia, CIBMTR, and Pfizer shared practical insights and emerging solutions. Access the on-demand recording, slides, and related resources here.
May 8: In the webinar “A Shared Language for Clinical Research: How Technical Organizations are Implementing the Clinical Research Glossary,” leaders from the Society for Clinical Data Management (SCDM), the Clinical Data Interchange Standards Consortium (CDISC), and the MRCT Center explored how adopting plain-language best practices—anchored by the Clinical Research Glossary—enhances clarity and engagement across both technical and participant communities. They shared case studies and practical strategies for embedding health-literacy tools into data-science workflows to foster a more accessible research ecosystem. Access the on-demand recording, slides, and related resources here.
May 10-14: Sarah White and Barbara Bierer attended International Council for Harmonisation (ICH) meetings in Madrid, Spain. The MRCT Center is an ICH training partner; Ms. White and Dr. Bierer met with the ICH E6(R3) Expert Working Group.
May 15: Carolyn Chapman, on behalf of her co-authors, presented two posters at the American Society of Gene and Cell Therapy (ASGCT) annual meeting in New Orleans, LA: “Characteristics of Long-Term Follow-Up Studies for Gene Therapies registered in ClinicalTrials.gov” and “Ethical, legal, and social issues (ELSI) in human somatic gene therapy clinical research: A Scoping Review.”
May 15: 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.” This forum is part of a series of convenings.
May 18 – 21: Sylvia Baedorf Kassis, MPH, was a co-panelist in a session entitled “Beyond the Buzzword: Putting Diversity Strategies to Work” at the annual MAGI conference in Boston, MA.
May 29: Barbara Bierer presented on “Increasing diversity in clinical trials through action-oriented initiatives” at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) annual meeting in Washington, DC.
June 2, 9:00 – 11:00 AM ET: Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting. See Spotlight above
June 4, 1:00 – 3:00 PM ET: Meeting of the Bioethics Collaborative. Topic: Therapeutic Misconception Revisited. For more information about the Bioethics Collaborative and how to join, click here.
June 5, 10:00 AM – 12:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: Trump Administration Changes to Notice and Comment Rulemaking at the U.S. Department of Health and Human Services; Certificates of Confidentiality: Background and Practical Implications. For more information about the Research, Development, and Regulatory Roundtable (R3) and how to join, click here.
June 6, 11:00 AM – 12:00 PM ET: Carolyn Chapman will be a speaker for the June edition of the webinar series, Bridging the Gap: Connecting Science, Industry, and Care to Advance Cell & Gene Therapy Webinar Series, sponsored by Azenta Life Sciences and the Emily Whitehead Foundation. The panel discussion topic is “Ethical issues in CGT trials: Benefits, Risks, Long Term Follow-Up, and beyond.”
June 10, 10:00 AM – 1:00 PM: “From Barriers to Breakthroughs: Funding, Resources, and Support to Improve Clinical Trial Access and Innovation.” The Convergence Project, hosted by FasterCures, in partnership with the MRCT Center, will convene virtually to explore actionable strategies for dismantling financial and structural obstacles to trial participation. Leaders from the Foundation for the National Institutes of Health, the American Cancer Society, Eli Lilly, Pfizer, Walgreens, and the Michael J. Fox Foundation will evaluate funding models, address participant cost and insurance challenges, and showcase sustainable, equitable partnership approaches. Click here to register.
June 16-20: Barbara Bierer and Sarah White will travel to Tanzania to meet with representatives from the National Health Research and Ethics Committee (NatHREC) and the Tanzania Medicines and Medical Devices Authority (TMDA). This work is part of the ongoing TRACE (Trial Regulation and Clinical Ethics Optimization) Project —an initiative to streamline and harmonize clinical trial regulation and ethics review across the region.
June 24, 12:00 – 1:00 PM ET: Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process. See Spotlight above.
June 24, 3:00 – 4:00 PM ET: A Framework for AI Adoption and Oversight in Clinical Research. See Spotlight above.
June 26, 1:00 – 2:00 PM ET: Patient-Centered Approaches for Gene Therapy Long-Term Follow-Up. See Spotlight above.
July 17: The MRCT Center and Vivli will co-facilitate an invite-only forum, “From Policy to Practice: Implementing the European Health Data Space (EHDS) for Responsible Data Sharing.” This forum is part of a four-part series of convenings.
Publications
May 8: Barbara Bierer and Willyanne DeCormier Plosky, together with Emily Nguyen (University of Virginia), David Resnik (NIEHS/NIH), and others published “An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity” in the Journal of Empirical Research on Human Research Ethics. The paper shows that IRB practices—often geared toward exclusion—can undermine the equal-opportunity participation rights guaranteed by Section 504 of the Rehabilitation Act for people whose capacity may be affected by medication, cognitive or developmental disabilities, psychiatric disorders, dementia, trauma, or stress. Unless an individual is formally deemed incapacitated and needs a legally authorized representative, they should be allowed to decide for themselves—using supported decision-making if desired—and be offered an equal chance to enroll in clinical trials.
May 12: Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by David Gerber (UT Southwestern), in the Journal of Clinical Oncology titled, “Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions.” This work was spearheaded by the Equitable Access to Clinical Trials (EACT) Project, hosted by Lungevity, of which the MRCT Center is one participating organization. The article illustrates that some of the non-medical costs that cancer trial participants often pay out-of-pocket are an additional stressor during a difficult time for participants and their families. The authors then detail financial support approaches to address these costs and special considerations for sponsors, contract research organizations, and sites. Finally, the article highlights recently introduced federal legislation that could significantly ameliorate some of the barriers for sponsors trying to implement financial support approaches and for participants trying to access them.
May 15: Carolyn Chapman co‑authored a Molecular Therapy commentary, “Patient‑centered long‑term follow‑up for gene therapies aligns with ethics and science,” which advocates burden‑light, patient‑driven follow‑up using decentralized tools and real‑world data, underpinned by strong patient engagement and cross‑disciplinary collaboration. Read it free through July 4, 2025, here.
May 23: In “Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment,” published in the Journal of Law, Medicine & Ethics (2025), Barbara Bierer and colleagues analyze how federal means-tested benefit rules—across Medicaid, Supplemental Security Income, SNAP, and TANF—treat even modest clinical trial stipends as countable income, deterring low-income, elderly, disabled, rural, and other underserved populations from participation. They show that these hidden economic disincentives undermine efforts to achieve representative trial cohorts and exacerbate disparities. To address this barrier, the authors urge Congress to expand the Ensuring Access to Clinical Trials Act of 2015 and enact new legislation excluding all clinical trial payments from gross-income calculations for means-tested programs—an essential reform for ethical, inclusive research.
May 30: The LGBTQIA+ Inclusion by Design in Clinical Research Toolkit has been updated to Version 2.0. Principal changes include an updated introduction, an additional example of eligibility criteria language (in Tool 2, Inclusive Language), and a revised version of Tool 7 (Exit Survey), with the new Tool 7 Appendix illustrating key resources and recommendations for SOGI data collection.
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