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.
LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
The compiled LGBTQIA+ Inclusion by Design in Clinical Research Toolkit is now available.
Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the ethical principles of respect for persons, beneficence, and justice, we have developed a toolkit to support the equitable participation of people who are LGBTQIA+.
The toolkit contains seven tools. Anyone can use the toolkit, although the first four tools, released in the spring of 2024, are directed more toward sponsors and research teams, and the latter three, released here, are directed more toward participants. We invite you to explore the toolkit or to find, adapt, and use the tools you find most relevant to your individual and/or organizational journey.
· LGBTQIA+ Inclusive Imagery Case Study
· LGBTQIA+ Inclusive Language Checklist
· SOGI Data Collection Checklist
· Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective
· Participant Questionnaire Inclusive of the LGBTQIA+ Participant Perspective
· Exit Survey Inclusive of the LGBTQIA+ Participant Perspective
New Representation in Research Resources
Representation in Research now combines the Diversity, Equity, and Inclusion (DEI) website landing page and microsite and is intuitively organized by sub-project (e.g., population group) rather than by the resource type (e.g., toolkit, webinar). We invite you to explore this comprehensive resource.
New Podcast Episode
Episode 2 of the Trials Beyond Borders podcast is now available on all streaming platforms. In this episode, Racquel Bruton, Associate Director and Clinical Trials Diversity Portfolio Lead at Biogen, and Willyanne DeCormier Plosky, MRCT Center Program Director, discuss how sponsor companies are enhancing representation in clinical trials, particularly outside the US. Racquel highlights Biogen’s longstanding commitment to reaching underrepresented populations and explores how the MRCT Center’s roadmap can help organizations develop effective diversity action plans.
Tune in to learn practical insights on operationalizing diversity strategies, now available on all streaming platforms and here.
Join Us: December Biannual Meeting of the Joint Task Force for Clinical Trial Competency
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Upcoming Meeting: The next biannual JTF meeting, open to the public, will occur on December 10, 9–11 AM ET. These virtual meetings are designed to accommodate global partners and stakeholders.
Agenda Highlights:
· Launch of a participant and patient partner competencies task force.
· Delphi results from the Data Management Task Force.
· Proposed team science competencies.
· Updates on the Portuguese translation of JTF resources.
· Results from the JTF competency survey conducted in the Philippines.
· Training community workers using the JTF framework.
Click here to register.
Join us for a Virtual Meeting on Clinical Trial Diversity
On December 9, the MRCT Center, in collaboration with the Clinical Trials Transformation Initiative (CTTI) and Milken Institute’s FasterCures, and with contributions from the National Academies of Sciences, Engineering, and Medicine, will host a virtual meeting to discuss the current state of diversity in clinical trials.
This meeting is part of the ongoing Diversity Convergence Project series, which began in 2023 and will feature insights from community leaders, policymakers, and researchers. Together, we will examine how the post-election policy landscape may impact efforts to enhance diversity in clinical trials.
The webinar is free to attend and will take place from 10:00 am to 1:00 pm ET.
Click here to register.
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 14th annual CCTSI Research Ethics Conference at the Colorado Clinical and Translational Sciences Institute.
November 12: Barbara Bierer presented and moderated “Patient Advocacy in Cell and Gene Therapy” at the Mass General Brigham Gene and Cell Therapy Research Symposium.
November 13-15: The MRCT Center’s Annual Symposium brought together over 120 in-person and approximately 400 virtual registrants worldwide to discuss pressing topics in clinical research. The program, held on the Harvard Medical School campus, featured a keynote address by Dr. Khair ElZarrad, Director of the FDA’s Office of Medical Policy, and highlighted collaborative approaches to advancing equity, innovation, and global harmonization in clinical trials. The event also included the conference Innovations in Data Sharing, which was presented in collaboration with Vivli.
The MRCT Center at PRIM&R Annual Conference:
- November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Elyse Summers (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) presented “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
- November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) presented “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?”
- November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky joined Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.
- November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) presented“Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.
- November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky presented with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
- November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky moderated a panel titled “Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel featured Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.
November 20: Barbara Bierer presented “Research Misconduct: New Regulations, prevention, and Integrity” at the Allegany-Singer Research Institute.
December 5: Carolyn Chapman, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor a webinar, “What’s up with Long-Term Follow-Up: ethical, regulatory, operational challenges,” with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine. The webinar is part of PGTME’s fifth annual Lunchtime Lecture Series.
Click here to register.
December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.
December 10, 12 pm ET: Carolyn Chapman will present “Science Applications and Ethics of Cell and Gene Therapy” at an Institute for Advanced Clinical Trials for Children (I-ACT) webinar.
Click here to register.
December 12, 9 – 11:30 am ET: Meeting of the Bioethics Collaborative. Topic: Is it Time to Retire the Concept of Deidentification?
January 9, 1:00 – 3:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable. Topic: Recent FDA Guidance Documents on Clinical Trials: Decentralized Clinical Trials, Considerations for Generating Clinical Evidence from Oncology Multi-regional Clinical Development Programs, and Diversity Action Plans.
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
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