In the Spotlight
New Resources for Post-Trial Responsibilities – Continued Access
The Post-Trial, Continued Access Responsibilities to Investigational Significant-Risk Device Framework: Scenarios that Require Further Consideration outlines five key milestones, specific scenarios, and considerations to support organizations in making equitable and transparent decisions regarding continued access to investigational significant-risk devices.
A companion framework addressing investigational medicines is also available. Both frameworks are intended to be used alongside the Principles of Post-Trial Responsibilities – Continued Access, a set of 12 foundational principles that define the shared obligations of stakeholders in ensuring appropriate post-trial continued access.
To learn more about the Post-Trial Responsibilities – Continued Access, click here.
Advancing Pediatric Platform Trials: Resources and Podcast
The MRCT Center hosted a 2-day hybrid meeting in Washington, DC, in October 2024 to examine the potential benefits, challenges, and opportunities of platform trials for pediatric populations. Approximately ~80 pediatric and platform trial experts from Europe, the U.K., Asia, Australia, and the U.S. were in attendance. In addition to common elements across pediatric platform trials, three diseases – pediatric oncology, major depressive disorder (MDD), and multidrug-resistant tuberculosis (MDR-TB) – were chosen to represent different conditions, epidemiology, settings, therapeutic challenges, and patient populations, and to illuminate different potential approaches and solutions. Overall and disease-specific recommendations were made, and we are delighted to share the comprehensive workshop report, and a detailed summary of the meeting proceedings.
This work is continuing. Each subgroup is continuing to meet and take concrete steps, maintaining momentum. The MRCT Center remains actively involved with each disease-specific subgroup to facilitate the next steps.
We appreciate the financial support of several companies, without whom this workshop would not have been possible. The workshop was supported in part by voluntary contributions from AstraZeneca, Johnson & Johnson, and Sanofi. Our thanks to all the individuals who contributed their time and expertise to planning and to those who attended the workshop, without whom this event would not have been possible.
We are pleased to present a companion podcast featuring a discussion with conference keynote speaker Dr. Danny Benjamin, renowned pediatrician, researcher, and champion of clinical trial innovation. Dr. Benjamin discusses how platform trials can address persistent gaps in pediatric therapeutic development and why a coordinated, multi-stakeholder approach is critical to success. His insights, drawn from decades of leadership in this space, speak directly to the opportunities and operational challenges detailed in the MRCT Center’s post-conference report. The episode is available on all streaming platforms; click here to listen on Spotify.
New Data Literacy Resources
The MRCT Center has been honored to collaborate with the PHUSE Data Transparency team on the development of educational materials addressing Data Privacy and Data Sharing. These resources, including five infographics in both English and Spanish, complement five videos and were presented at a webinar on April 3. The recording and slides are now available on-demand here.
These infographics and videos are freely available and designed to explain to potential participants, their allies, and the public how data are used and protected in clinical research research.
Advancing Patient Partner Engagement in Clinical Research
The MRCT Center and the Joint Task Force for Clinical Trial Competency (JTF), in collaboration with CANTRAIN and EUPATI, have launched a new international initiative to promote more inclusive, impactful, and patient-centered research. Co-Creating Clinical Research Competencies to Support Effective Patient Partner Engagement Activities brings together patient partners, researchers, industry representatives, and study staff to expand the JTF Framework by addressing the role of patient partners in clinical research. We plan to define both (1) the key competencies for patient partners as co-leaders and advisors and (2) the skills that research professionals need to engage effectively with patient partners.
Updates will be shared throughout 2025, with outcomes anticipated in 2026.
Now Available on WHO Academy
Our course, “Ethics and Review of Interventional Clinical Research,” is now available on WHO’s new and revitalized online learning platform, WHO Academy. This course has already had an impact; over 5,000 learners from over 150 countries enrolled in it in its first three months.
The course provides a foundational understanding of key scientific and ethical issues in the design and review of interventional clinical trials. It is tailored to research ethics committee members, chairs, and staff, and will benefit regulators, investigators, study staff, care providers, and others involved in clinical trials.
This course is available free of charge worldwide. Click here to create a WHO Academy account to enroll.
Upcoming MRCT Center Webinars
Join us on Tuesday, May 6, from 1:00–2:00 PM ET, to discuss innovative approaches to long-term follow-up (LTFU) in gene therapy (GT). While GTs may offer transformative health benefits, long-term safety monitoring is often essential and can span years or decades. Our panelists will explore scientific and logistical challenges, along with emerging solutions.
Panelists:
- Dr. Barbara Konkle (Washington Center for Bleeding Disorders, University of Washington, Bloodworks NW) on the World Federation of Hemophilia’s Gene Therapy Registry, a global effort to track long-term outcomes in hemophilia.
- Dr. Amy Moskop (Medical College of Wisconsin, CIBMTR) on the CIBMTR registry and its role in GT LTFU.
- Dr. Avery McIntosh (Pfizer) on safety study design, platform protocols, and master protocol approaches, drawing from recent publications.
Moderator: Dr. Carolyn Riley Chapman, MRCT Center.
May 8: 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 Thursday, May 8, from 10:00–11:00 AM ET, to discuss how technical data sciences organizations are 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 and patient-centricity to improve understanding and engagement.
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:
- Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
- How Arizona State University’s Clinical Research Management program integrates the JTF Framework into both its curriculum and accreditation approach
- Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
- Results from a Delphi study on data management competencies
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—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
April 3: The MRCT Center hosted a webinar on global development of clinical research workforce tools and resources, featuring international perspectives on implementation of the JTF Clinical Trial Competency Framework. The webinar and accompanying materials are now available on demand here.
April 3: The MRCT Center and PHUSE presented co-produced resources to support data literacy, including five infographics in both English and Spanish, as well as videos, at a recent webinar. The recording and resources are now available on demand here.
April 8: Willyanne DeCormier Plosky joined 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: Willyanne DeCormier Plosky spoke 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 24–27: Sylvia Baedorf Kassis spoke at the Association for Clinical Research Professionals (ACRP) Annual Conference in New Orleans, LA, where she presented in two sessions focused on: (1) representation in clinical trials and (2) integrating participant perspectives into clinical research materials.
April 25: Barbara Bierer spoke at the International Association of Clinical Research Nurses (IACRN) Annual Symposium on “The Background of Decentralized Trials and Ethical Considerations.”
May 6: 1:00 – 2:00 PM ET: Innovative Approaches to Gene Therapy Long-Term Follow-Up: Leveraging Registries and Platform Trials. See Spotlight above.
May 8: 10:00 – 11:00 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. As the ICH training partner, Ms. White and Dr. Bierer will be meeting with the ICH-E6(R3) Expert Working Group.
May 15: From Policy to Practice: Implementing the EHDS for Responsible Data Sharing. Organized by the MRCT Center and Vivli, this ongoing forum is open to MRCT Center Executive and Steering Committee sponsors and Vivli members. For more information about how to become a sponsor, click here.
May 29, 1:30 – 3:00 PM ET: Barbara Bierer will present 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 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 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.
Publications
April 21: Mark Barnes, Barbara Bierer, and colleagues published “Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions” in the Journal of Law, Medicine & Ethics. The article synthesizes prior defamation cases related to research misconduct and offers guidance for institutions and other stakeholders to minimize potential defamation liability during such proceedings.
April 25: In a commentary published in Trials, “Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America”, Barbara Bierer and colleagues underscore the urgent need for sustained, cross-sector collaboration to protect and advance diversity in U.S. clinical research. Given the importance of representativeness of the participant population, the authors highlight practical, unified strategies—emerging from the 2023 Stanford Think Tank—to ensure inclusive participation across the clinical research enterprise.
MRCT Center News
Left to right: Lolade Adeyemi, Special advisor on Research and Innovation to the Honorable Minister of Education, Federal Republic of Nigeria; Katherine Littler, Co- Lead, Global Health Ethics and Governance Unit, WHO; Roli Mathur, Scientist G and Head, Indian Council of Medical Research (ICMR); Barbara Bierer, Faculty Director, MRCT Center; and Andreas Alois Reis, Co-lead, Global Health Ethics and Governance, WHO.
Barbara Bierer attended “the 2nd WHO Global Clinical Trials Forum: Action for Impact” meeting in Geneva, Switzerland. The discussions focused on advancing the WHA75.8 implementation globally and included a specific review of the Global Action Plan.
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.