Newsletter Archives

November 2025 Newsletter

In the Spotlight

New Toolkit for Long-Term Follow-Up

In early November, the MRCT Center released the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies as a draft for public comment. The resource offers practical, actionable guidance for best practices across long-term follow-up (LTFU) studies for both investigational and approved gene therapies, balancing the need to generate essential long-term safety and efficacy data with the obligation to reduce burden on participants, caregivers, sponsors, and investigators. Its interactive structure—with clickable toolbars, intuitive navigation, and clearly organized sections spanning Guiding Principles, Types of LTFU Studies, Considerations and Recommendations, Key Design Elements for FDA-approved products, regulatory references, glossaries, and appendices—helps users move quickly from concept to implementation.

Stakeholders have emphasized the value of the toolkit’s pragmatic approach. They highlighted its emphasis on engaging patients as partners and ambassadors; applying the Goldilocks principle to right-size expectations; embedding patient-centricity into every stage; and using decentralized approaches when appropriate. They also praised its attention to adaptability, recognizing that program adjustments over time are expected, and its thoughtful integration of real-world data. Importantly, the toolkit encourages teams to consider not only disease-specific factors but also the needs and contexts of patient communities, families, advocacy groups, and global treatment environments.

The Toolkit remains open for public comment. Please share your feedback by Friday, December 19, by emailing us at mrct@bwh.harvard.edu

Explore the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies and watch the on-demand toolkit release webinar.

EC/IRB Guide to Understanding Post-Trial Continued Access

In early November, the MRCT Center released the EC/IRB Guide for Understanding Post-Trial Continued Access, which aims to assist Ethics Committees (EC) and Institutional Review Boards (IRB) in interpreting their role under Paragraph 34 of the Declaration of Helsinki. Paragraph 34 requires sponsors and researchers to arrange post-trial provisions for “participants who still need an intervention identified as beneficial and reasonably safe.” Exceptions to this must be approved by an EC or IRB, necessitating an understanding of when post-trial, continued access is applicable.

This resource outlines principles and criteria for evaluating when continued access is appropriate. It provides tools and questions to guide equitable decisions, ensuring ethical and transparent approaches to post-trial, continued access decisions. Additional resources and frameworks are available through the MRCT Center’s Post-Trial Responsibilities: Continued Access project page to support ethics committees.

Implementing the MRCT Center’s Clinical Research Glossary

Many organizations are integrating the MRCT Center’s Clinical Research Glossary into their workflows, demonstrating its practical value in improving communication and participant understanding. Across seven published use cases, including two new ones from Pfizer and Biogen, learn more about how the glossary’s 216 plain-language terms, definitions, images, and linked resources are being used to strengthen patient-facing materials, support health-literacy training, and align technical content with global data standards.

These real-world examples underscore the glossary’s impact: clearer explanations, greater confidence among participants and caregivers, and more consistent communication across research teams.

As the glossary continues to grow through annual public review, we invite you to consider how a shared, plain-language vocabulary can advance informed decision-making and more equitable engagement in clinical research. To learn more about the Clinical Research Glossary, get involved, or submit your own use case, please click here.

Upcoming Webinars and Forums

Mitigating Financial Toxicity for Participants in Clinical Trials
Tuesday, December 9 | 10:00–11:00 AM ET

Hosted by the MRCT Center, in collaboration with Equitable Access to Clinical Trials (EACT), a project convened by LUNGevity Foundation.

Clinical trials are vital to advancing medical knowledge and care, yet participation can impose significant financial burdens on participants and their families—from travel and time away from work to uncovered medical and ancillary expenses.

This webinar will examine the sources and impact of these costs and highlight emerging strategies to reduce financial hardship for research volunteers. Presenters will also introduce tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation.

Panelists

Dr. David Gerber, Co-Director, Simmons Comprehensive Cancer Center Office of Education and Training; Professor, University of Texas Southwestern Medical Center
Wendy K.D. Selig, Founder and CEO, WSCollaborative

Moderator
Dr. Barbara Bierer, Faculty Director, MRCT Center

Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting
December 10, 1:00 pm – 3:00 pm

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—the knowledge, skills, and attitudes—needed to conduct safe, ethical, high-quality clinical research.

Join us on December 10, from 1:00–3:00 PM ET, for the JTF Biannual Global Meeting to learn from colleagues around the world who are implementing the JTF Framework in diverse contexts. Presentations will highlight how the Urdu translation of the Framework is advancing clinical research competencies in Pakistan; how professional standards and recognition are being strengthened for Australian clinical trials professionals; and how workforce development is being supported across New Zealand public hospitals. Speakers will also share approaches to designing experiential learning with a focus on JTF competencies at North Carolina Central University, as well as efforts to integrate the Framework into a master’s-level clinical data science training program.

Deploying Digital Twins and Synthetic Data in Evidence Generation
Thursday, January 15, 11:00 AM to 12:00 PM ET.

Please join us on Thursday, January 15, for the third webinar in the MRCT Center’s Digital Twins and Synthetic Data series. This session will examine the appropriate use of digital twins and synthetic data in evidence generation, including their potential role in regulatory submissions.

Panelists will discuss evidence quality, validation, and model transparency, and will reflect on the evolving regulatory landscape for these technologies in clinical research. The session will include a moderated discussion and time for audience Q&A.

Events & Presentations

November 4: Long-Term Follow-Up for Gene Therapies: Toolkit Release webinar. Resources from this webinar, including the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies, the recording, slides and related resources, are now available on-demand here.

November 4: The MRCT Center and Vivli co-host an ongoing, invitation-only forum focused on the European Health Data Space (EHDS). The discussion continues with stakeholders collaborating on developments and the coordination of work efforts. The November forum, the fifth to date, focused on responses to the TEHDAS2 guidance documents in the form of public consultation in key identified areas, and continued our efforts to guide policy development towards a harmonized data sharing system for secondary use purposes.

November 7-8: The MRCT Center at the PRIM&R 2025 Conference:

November 7, 10:30 – 11:45 AM ET: Barbara Bierer and Trevor Baker joined WCG collaborator Donna Synder, Tamiko Eto of Center for AI & Digital Policy (CAIDP), and David Clifford to present “Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical Tools.”
November 8, 12:30 – 1:30 PM ET: Barbara Bierer contributed to a roundtable discussion with Luke Gelinas of Advarra, and Benjamin Silverman and Martha Jones of Mass General Brigham, “Should we still be using Unconsented Biospecimens for Research in 2025?”
November 8, 12:30 – 1:30 PM ET: Barbara Bierer joined Polly Goodman and Jeremy Lavigne of Harvard University to present “Everything you wanted to know about SMART IRB Agreement Version 3.0.”
November 8, 12:30 – 1:30 PM ET: Willyanne DeCormier Plosky joined Tiffany Chenneville of the University of South Florida to present “Science Under Siege: Defending Scientific Integrity in a Polarized World.”

November 14: Sylvia Baedorf Kassis was a speaker at the International Society for Medical Publication Professionals (ISMPP) Academy. She co-led interactive sessions on Mastering Plain Language Summaries (PLS) and Plain Language Summaries of Publications (PLSP): Bridging Foundations and Applications.

November 17 and 19: Barbara Bierer conducted a 2-day, 6-hour virtual training with medical professionals from St. Luke’s Medical Center of the Philippines to introduce participants to the purpose and functioning of Data Safety Monitoring Committees (DSMCs). On the second day of the virtual training, Steven Snapinn, Ph.D., presented on biostatistical considerations for DSMC, a discussion moderated by Dr. Bierer.

November 18: AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research. This webinar, the second in this series, focused on real-world examples and lessons learned from deploying synthetic data and digital twins across therapeutic areas. Resources, including the recording, slides, and related resources, are now available on-demand here.

November 18: Carolyn Riley Chapman presented an overview of the MRCT Center’s Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies at the WCG-hosted webinar Beyond the Trial: Ethical Oversight in Gene Therapy Long-Term Follow-Up.

November 19: Barbara Bierer addressed “Resources for PI oversight in decentralized clinical trials” at the Innovation Evidence Workshop, a full-day meeting in Boston, presented by Medable in collaboration with Tufts Center for the Study of Drug Development at Tufts University School of Medicine.

December 8, 10:00 AM – 12:30 PM: Meeting of the Bioethics Collaborative. Topic: How Much Risk is Too Much? Revisiting the Ethics of Control Arms. For more information about the Bioethics Collaborative and how to join, click here.

December 10, 1:00 – 3:00 PM ET: Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting. See Spotlight above.

December 15-18: Dr. Barbara Bierer and Sarah White will be visiting Kenya as the fifth country in the TRACE project. Their itinerary includes meetings with the TRACE leadership team and key stakeholders within Kenya, including KEMRI, NACOSTI, PPB, and Moi University’s IRB. This baseline assessment will focus on regulatory and ethics systems coordination and optimization, capacity buildng and training needs, as well as an introduction to the WHO Ethics Benchmarking tool and financial sustainability models.

January 15, 11:00 AM – 12:00 PM ET: Deploying Digital Twins and Synthetic Data in Evidence Generation. See Spotlight above for details.

January 24: Carolyn Riley Chapman will co-lead a workshop on “What’s Special about Expanded Access for Gene and Cell Therapies?” at CUPACon26, NYU Langone Health’s Working Group on Compassionate Use & Preapproval Access (CUPA)’s biannual conference, hosted this year by Boston University School of Law. This workshop will be led in collaboration with Dr. Emma James of Encoded Therapeutics.

January 29: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: The HALT Fentanyl Act and its effects on research involving controlled substances; Declaration of Taipei. This meeting is open to sponsors of the Research, Development, and Regulatory Roundtable (R3). For more information about this ongoing forum and how to join, click here.

Publications

November 14: Carolyn Chapman, Mena Shaikh, Ava Glazier, Andrew Creamer, and Barbara Bierer published Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review in Human Gene Therapy. Dozens of gene therapies have been approved, and hundreds more are in development, prompting the need to better characterize the ethical, legal, and social implications (ELSI) of this emerging therapeutic class. The authors conducted a scoping review to map these issues across the literature, identifying themes related to risk–benefit assessment, engagement and communication, justice and access, ethical trial design, and the influence of financial and regulatory decision-making. The article also discusses potential approaches to address these ELSI as gene-therapy research expands.

MRCT Center Updates

Nandini Krishnamoorthy joined the MRCT Center as a Student Researcher in November 2025. Nandini will be providing support to various projects at the Center.

Nandini is a senior at Tufts University, studying Community Health. Across academic and professional experiences spanning clinical, academic, and community-based settings, Nandini has worked toward a commitment to advancing health equity at the intersection of clinical medicine, global health, and community-based 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.

October 2025 Newsletter

In the Spotlight

New ICH E6(R3) Training

The ICH E6(R3) Guideline for Good Clinical Practice (GCP) modernizes global standards for the ethical and scientific conduct of clinical trials.

To support its interpretation and implementation, the MRCT Center, in collaboration with the International Council for Harmonisation (ICH), is designing and developing a five-module course. The first module, Introduction and Foundational Concepts, has been released on the ICH Training Library and provides a clear orientation to the structure and intent of the Guideline—its principles, annexes, and appendices—and introduces foundational concepts such as quality by design, quality management, critical-to-quality factors, risk proportionality, and fit-for-purpose. This free, self-paced training is designed for investigators and their research teams, providers, sponsors, contract research organizations, IRB/IEC members, and regulators involved in interventional clinical research. Four additional modules are in development and will expand on key sections of the E6(R3) Guideline. The MRCT Center is an ICH Training Associate.

Access Module 1 here

Upcoming Webinars

October 30, 12:00 – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research

October is Health Literacy Month! Join us on Thursday, October 30, for the webinar Applied Health Literacy: Using Teach-Back in Conversations About Clinical Research.

Learn the essential elements of Teach-Back, why it matters for safe, equitable care and research, and practical ways to integrate it into clinical research conversations. The session will highlight how study teams can simplify complex information, confirm understanding, and foster dialogue with participants and caregivers throughout recruitment, consent, and beyond.

Registrants will receive tips and resources to apply Teach-Back in everyday research processes.

November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release

Join us as we mark the public release of the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies. Developed with multi-stakeholder input from industry, academic researchers, patients, patient advocates, and human research protection professionals, the Toolkit provides practical guidance to employ best practices to design and operationalize LTFU studies for both investigational and approved gene therapies.

The session will introduce the Toolkit’s structure and contents, including Guiding Principles, Considerations and Recommendations, and Looking Forward sections. The Toolkit also features other resources, such as key design elements of LTFU studies for FDA-approved gene therapies, international LTFU regulatory guidance, glossaries, and background information on types of LTFU studies.

We will be joined by three panelists who will share their experiences and perspectives and highlight key points and takeaways. There will be time for Q&A with the audience as well.

November 18, 12:00 pm- 1:00 pm ET: AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

This second session in our AI series will focus on real-world applications of digital twins and synthetic data in clinical research. Daniele Bertolini, Unlearn.AI, will discuss how these technologies can reduce reliance on traditional control arms, support Bayesian and single-arm trial designs, and optimize future trial planning and analysis.

The session will also examine emerging opportunities and limitations in applying AI-enabled models to clinical trials and how these approaches may advance trial efficiency and innovation in study design.

December 10, 1:00 pm – 3:00 pm: Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting

New Resource for Financial Neutrality in Cancer Trials

The MRCT Center has been part of a collective effort to advance financial neutrality for participants in cancer clinical trials by ensuring that financial support for out-of-pocket patient costs is available. This effort, the Equitable Access to Clinical Trials (EACT) initiative, involves a multi-stakeholder group of patient advocacy organizations, clinical trial site leaders, industry partners, CRO, and IRB colleagues.

A new resource, Advancing Equitable Access to Clinical Trials: Eliminating the Financial Burden for Patients, has been released. This document provides important information, recommendations, and a Call to Action for site personnel to advance financial neutrality in cancer trials.

Events & Presentations

September 11: The MRCT Center’s Artificial Intelligence (AI) and Ethical Research project continues to advance practical guidance for the responsible use of AI in clinical research, anchored by the Framework for Review of Clinical Research Involving Artificial Intelligence. Building on this work, WCG—our collaborator in developing the Framework—hosted a September 11 webinar with Barbara Bierer and Trevor Baker to demonstrate how the Framework can be applied in real-world review and oversight scenarios. Following the session, WCG released a new FAQ to support stakeholders in interpreting and operationalizing the Framework.

September 30: AI Digital Twins and Synthetic Data: Applications to Clinical Trials. The recording, slides, and related resources are now available on demand.

September 30: The MRCT Center and Vivli co-host an ongoing, invite-only forum focused on the European Health Data Space (EHDS), bringing together stakeholders to track developments and coordinate responses. This convening, the fourth in the series to date, prioritized upcoming TEHDAS2 guidance documents for public consultation and developed a strategy for collective feedback and submissions.

October 7: Sarah White joined Jane Williams and Meredith Wilson of Syneos Health, and Kemi Olugemo of Korro Bio, for the panel “Ethics in Action: Building Patient Protection in Clinical Trials Through Therapeutic Expertise” at the Fierce Biotech conference in Boston.

October 22: MRCT Center Annual Symposium. The MRCT Center convened global research stakeholders, both in-person in Boston and online, for its one-day Annual Symposium, “Meeting the Moment,” to advance ethical, actionable, and practical solutions for global clinical trials. John Crowley, President & CEO of the Biotechnology Innovation Organization (BIO), delivered the keynote, setting the stage for discussions on the need for clinical trial reform, rethinking informed consent with artificial intelligence, long-term follow-up for cell and gene therapies, and the path forward for participant-centered innovation. The program concluded with an interactive session on reinventing informed consent, inviting attendees to collaboratively reimagine the consent form and process for today’s research landscape.

October 23: Vivli Annual Meeting, co-hosted with the MRCT Center. “Data in Action: From Contribution to Impact.”

October 24: Trevor Baker, Barbara Bierer, and WCG collaborator Donna Snyder presented “Ethical Oversight of AI in Clinical Research: A Framework and Practical Implications” at the MAGI@home virtual conference.

October 30, 12:00 – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research. See Spotlight above

November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release Webinar. See Spotlight above.

November 4: The MRCT Center and Vivli co-host an ongoing, invitation-only forum focused on the European Health Data Space (EHDS). The discussion continues with stakeholders collaborating on developments and the coordination of work efforts. The November forum, the fifth to date, will focus on responses to the TEHDAS2 guidance documents in the form of public consultation in key identified areas, and continue our efforts to guide policy development towards a harmonized data sharing system for secondary use purposes.

November 7-8: The MRCT Center at the PRIM&R 2025 Conference:

November 7, 10:30 – 11:45 AM ET: Barbara Bierer and Trevor Baker will join WCG collaborator Donna Synder, Tamiko Eto of Center for AI & Digital Policy (CAIDP), and David Clifford to present “Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical Tools.”
November 8, 12:30 – 1:30 PM ET: Barbara Bierer will contribute to a roundtable discussion with Luke Gelinas of Advarra, and Benjamin Silverman and Martha Jones of Mass General Brigham, “Should we still be using Unconsented Biospecimens for Research in 2025?”
November 8, 12:30 – 1:30 PM ET: Barbara Bierer will join Polly Goodman and Jeremy Lavigne of Harvard University to present “Everything you wanted to know about SMART IRB Agreement Version 3.0.”
November 8, 12:30 – 1:30 PM ET: Willyanne DeCormier Plosky will join Tiffany Chenneville of the University of South Florida to present “Science Under Siege: Defending Scientific Integrity in a Polarized World.”

November 14: Sylvia Baedorf Kassis will be a speaker at the International Society for Medical Publication Professionals (ISMPP) Academy. She will be co-leading interactive sessions on Mastering Plain Language Summaries (PLS) and Plain Language Summaries of Publications (PLSP): Bridging Foundations and Applications.

November 18, 12:00 pm- 1:00 pm ET: AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research. See Spotlight above.

December 10, 1:00 – 3:00 PM ET: Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting. See Spotlight above.

Publications

October 16: In the article, A Scoping Review of Challenges in Pediatric Health Technology Assessments with a Focus on Pharmaceutical Interventions, published in the International Journal of Technology Assessment in Health Care, authors Nora Hutchinson, Lauren Otterman, Elisa Koppelman, Barbara Bierer, and colleagues highlight the substantial difficulties in incorporating children within the population-wide health technology assessment (HTA) system, as well as the uncertainty accompanying pediatric HTAs due to data constraints, lack of guidance and/or variation in guidance, between HTA bodies.

October 22: In the article “Characteristics of long-term follow-up studies for gene therapies registered on ClinicalTrials.gov,” published in Gene Therapy, co-authors Carolyn Chapman, Emina Berbic, Ava Glazier, and Barbara Bierer describe key characteristics of LTFU gene therapy study protocols registered in ClinicalTrials.gov. Analyzing how registered LTFU studies are currently designed, the results suggest a lack of harmonization in how safety outcomes are monitored and reported across LTFU studies. Standardization and/or harmonization of data and outcome reporting may increase the scientific value of these studies.

September 2025 Newsletter

In the Spotlight

JOIN US! MRCT Center 2025 Annual Symposium

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.

We are pleased to announce our keynote speaker: John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), a biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. John’s decades of biotech experience and deep passion for the field have made him a strong supporter of policies that empower innovation, enable entrepreneurship, and put people and patients first.

Other highlights of the agenda include the following:

Rethinking Informed Consent with Artificial Intelligence: Opportunities and Challenges
Cell and Gene Therapies Long-Term Follow-Up: Key Deliverables and the Path Forward
Reinventing Informed Consent: Emerging from the Chrysalis
Clinical Trial Reform: The Need for Change and Progress

On Thursday morning, October 23, the MRCT Center will hold a joint meeting in concert with the Vivli annual meeting. Researchers, data contributors, and funders will discuss the journey from data contribution to impact in clinical trial methodology, oncology, and Type 1 diabetes. Sessions will focus on learnings from data challenges, the latest in sharing imaging data, as well as how to apply the latest DOJ ruling on sharing data with countries of concern. This event is also complimentary and open to all Symposium registrants.

The Clinical Research Glossary: Now Expanded to 216 Words

The MRCT Center’s Clinical Research Glossary helps participants, patients, and care partners make informed decisions about clinical research by explaining complex terms in clear, plain language. Everyone—regardless of background—has the right to understand, ask questions, and fully engage in the research process. The glossary also supports research professionals in fostering clear, meaningful dialogue with participants throughout a study.

In collaboration with CDISC, we’ve added 29 new terms. The glossary now includes 216 terms, definitions, images, and related content, and is freely accessible under a Creative Commons license. Click here for an updated FAQ with a Summary of Changes.

Explore, download, and share the glossary—and help make clinical research clearer for all. Submit feedback or suggest additional terms here.

Upcoming Webinars

October 30, 12:00 PM – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research

October is Health Literacy Month! Join us on Thursday, October 30, from 12 – 1 PM ET for the webinar Applied Health Literacy: Using Teach-Back in Conversations About Clinical Research.

Registrants will receive tips and resources to apply TB in everyday research processes.

November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release

Long-term follow-up (LTFU) studies are essential to assess the benefit–risk profile of gene therapies. Yet they are difficult to design and carry out, placing burdens on both participants and sponsors.

In September 2024, the MRCT Center convened a working group on LTFU studies for gene therapies. The group includes patients and representatives from pharmaceutical companies, clinical research organizations, academic medical centers, institutional review board oversight, and patient advocacy organizations.

This webinar will introduce a Toolkit for Supporting the Design and Conduct of Long-Term Follow-Up Studies for Gene Therapies, which is being released as a draft for public comment. Members of the working group will share their perspectives on the Toolkit’s development and discuss next steps. The session will conclude with audience questions and discussion.

Events & Presentations

September 8: Meeting of the Bioethics Collaborative. Topic: Ethics of Rare Diseases. For more information about the Bioethics Collaborative and how to join, click here.

September 9: 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.” International representatives fielded questions related to EHDS challenges, areas of uncertainty, or provisions that remain unclear.

September 12: Continued Access to Investigational Products: Guiding Equitable and Fair Decisions: This webinar, now available on demand, explored the MRCT Center’s work to address the challenges of post-trial, continued access, emphasizing that planning for the continued provision of investigational medicines or devices must begin before a trial starts. It highlighted principles and frameworks developed by the Post-Trial Continued Access Task Force, including a case study on difficult decisions when a trial’s primary endpoint fails but a subpopulation benefits.

September 14: Barbara Bierer presented a lecture on “Optimizing Representation in Clinical Research in an Interconnected, Global World” at the Second International Conference of the Japanese Association for Philosophical and Ethical Research in Medicine (JAPERM), held at Kanagawa University in Yokohama, Japan.

September 16: Barbara Bierer presented two talks, “Training and Professional Development of Research and Ethics Professionals” and “Patient and Public Involvement (PPI) in Advanced Cell and Regenerative Therapies,” to members of the RIKEN Institute, the premier Japanese research organization, and Osaka University.

September 22: Sarah White and Carmen Aldinger, along with Rebecca Li and Julie Wood of Vivli, hosted the 2025 Mansfield-PhRMA Research Scholars in Boston. Presentations related to the work of the MRCT Center and Vivli were provided to the scholars.

September 25: Willyanne DeCormier Plosky led a discussion of the article “Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification | Health Affairs” at the most recent MGB Disability Employee Inclusion Alliance lunch-and-learn session.

September 25: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: China Revisited: Recent Developments Affecting Research Involving the People’s Republic of China (“PRC”). For more information about R3 and how to join, click here.

September 26-28: Barbara Bierer opened this year’s Society for Clinical Research Associates (SOCRA) conference in Chicago, IL, participating in the opening plenary panel entitled, “Research Advocacy Under a New Administration: Insights and Actions.” Sylvia Baedorf Kassis delivered the closing plenary address, focusing on strategies for prioritizing conference takeaways, lessons learned, and new resources to increase impact.

September 30: AI Digital Twins and Synthetic Data: Applications to Clinical Trials. On-demand webinar resources will be posted to the MRCT Center website soon.

September 30: The MRCT Center and Vivli co-host an ongoing, invite-only forum focused on the European Health Data Space (EHDS), bringing together stakeholders to track developments and coordinate responses. This convening, the fourth in the series to date, will prioritize upcoming TEHDAS2 guidance documents for public consultation and develop a strategy for collective feedback and submissions.

October 22, 8:00 – 5:00 PM ET: MRCT Center Annual Symposium. See spotlight above for details.

October 23: 8:30 – 3:30 PM ET: Vivli Annual Meeting, co-hosted with the MRCT Center. “Data in Action: From Contribution to Impact.” See Spotlight above for details.

October 24, 2:30-3:30 pm: Trevor Baker and Barbara Bierer will be joined by Donna Snyder (WCG) to present, “Review Framework for Clinical Research involving AI” at the MAGI@ home Boston conference.

November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release Webinar. See Spotlight above.

November 8: Willyanne DeCormier Plosky will speak, with co-panelists Tiffany Chenneville (University of South Florida) and Cheri Pettey (Advarra), at the PRIM&R 2025 Conference Lunch Networking Session, “Science Under Siege: Defending Scientific Integrity in a Politicized World.”

Nov 14: Sylvia Baedorf Kassis has been invited to speak at the International Society for Medical Publication Professionals (ISMPP) Academy.

Publications

September 18: The MRCT Center submitted public comments on the draft ICH E21 guidance regarding the inclusion of pregnant and breastfeeding women in clinical trials. The MRCT Center strongly supports the ethical inclusion of these historically understudied populations and emphasized the need for ethical and rigorous, well-designed research guided by participant and individual protections.

July/August 2025 Newsletter

In the Spotlight

JOIN US! MRCT Center 2025 Annual Symposium

Other highlights of the agenda include the following:

Rethinking Informed Consent with Artificial Intelligence: Opportunities and Challenges
Cell and Gene Therapies Long-Term Follow-Up: Key Deliverables and the Path Forward
Reinventing Informed Consent: Emerging from the Chrysalis
Clinical Trial Reform: The Need for Change and Progress

New Project: Reproductive Health Considerations in Clinical Research

The Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization introduced new challenges for the conduct of clinical trials involving people of reproductive potential, for the study of pregnancy-related conditions, and for participants in clinical research and research staff. Among other concerns, the legislation—and the patchwork of state laws that followed—has introduced new privacy concerns for clinical trial participants and others. The MRCT Center is using both empirical and normative approaches to frame new recommendations and a practical toolkit for improved practices in research.

September Webinars

September 12: Continued Access to Investigational Products: Guiding Equitable and Fair Decisions

Please join us on Friday, September 12, from 11 AM – 12 PM ET for a webinar to discuss the MRCT Center’s ongoing work related to the challenges of post-trial continued access to investigational products. Post-trial continued access is a shared responsibility and should be addressed before the trial begins. Even with the best planning, complex situations arise that require research sponsors to balance various tradeoffs and impacts on stakeholders. The MRCT Center’s Post-Trial Continued Access Task Force has developed resources to guide equitable and fair decision-making related to the continued provision of the investigational medicine or continued maintenance of the investigational significant risk device after the trial.

This webinar will introduce a series of resources, including principles, frameworks, and recommendations. Case studies will also be presented to illustrate unique complexities that sponsors and investigators must consider.

September 30: AI Digital Twins and Synthetic Data: Applications to Clinical Trials

Please join us on Tuesday, September 30, from 11:00 AM – 12:30 PM ET for a webinar on the applications of AI digital twins and synthetic data to clinical trials. Digital twins are simulated models of individual patients designed to predict disease trajectories and/or treatment responses, offering the potential to enhance statistical power, optimize trial design, and reduce the number of participants assigned to a control arm. Synthetic data are artificially generated datasets that mirror the statistical properties of verified clinical data.

Both technologies are being developed for use in the design, conduct, and analysis of clinical trials, with potential applications in regulatory submissions. This webinar will introduce these emerging technologies and explore their implications, opportunities, and challenges in clinical research.

Key Topics:

Overview of digital twins and synthetic data, including how they differ from traditional statistical modeling.
Ethical, statistical, and regulatory considerations for adopting these technologies in clinical trial design and conduct.
Panel discussion with expert perspectives on the evolving role of AI digital twins and synthetic data in clinical research.

Events & Presentations

July 14-16: Lisa Koppelman led an interactive session at the iCAN 2025 Summit in Montreal titled “Time for a Reboot: Updating the Including Young People in Research Toolkit.” Young people and adult stakeholders from clinical research and related fields reviewed the engagement model that underpins the toolkit. The work continues with interested youth joining a reference group tasked with reviewing and updating the Including Young People in Research toolkit.

July 17: 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.” The forum, held periodically, brings together stakeholders to examine the operational, ethical, and regulatory dimensions of EHDS implementation. The July session featured an update from EFPIA, emphasizing the need for harmonized data governance across EU member states and addressing challenges in data protection and compliance.

July 24–25: Advancing Childhood Cancer Academic-Industry Collaborative Platform Trials Workshop. The MRCT Center, Innovative Therapies for Children and Adolescents with Cancer (ITCC), the Children’s Oncology Group (COG), and Blood Cancer United hosted a two-day workshop in Washington, DC, building on the October 2024 Advancing Paediatric Platform Trials: Streamlining Development, Maximizing Impact event.

Supported by charitable donations from Cancer Research UK, LifeArc, Solving Kids Cancer, KICKcanER, Andrew McDonough B+ Foundation, and Blood Cancer United, the meeting brought together stakeholders from the UK, Europe, and the US to accelerate academic-industry collaboration in pediatric oncology platform trials. Participants—including academia, pharma, international regulators, and patient advocates—identified joint actions to address barriers and expedite access to safe, effective treatments for young people with cancer. The Planning Committee is now developing priority materials for broad dissemination in the coming months.

July 28–31: Barbara Bierer attended a face-to-face meeting in Kigali, Rwanda, for the Trial Regulation and Clinical Ethics Optimization (TRACE) project. The meeting focused on reviewing progress across the project’s workstreams and included hands-on working sessions with country representatives from Nigeria, Rwanda, Tanzania, and Zimbabwe to support ongoing implementation efforts.

August 13: Sylvia Baedorf Kassis was featured in the Agency for Healthcare Research and Quality (AHRQ)-funded roundtable series “ASTARISQ,” highlighting changemakers who are working to improve safety, quality, and trustworthiness in health delivery systems. With her co-panelists, Sylvia addressed Health Literacy and Credible Messengers as critical to increasing clinical research access, understanding, and enrollment.

August 18: Barbara Bierer and Trevor Baker were joined by co-lead Donna Snyder of WCG to deliver a virtual lecture on “Reviewing Human Research Protocols involving AI: A Framework and Practical Implications” to members of the Uganda National Council for Science and Technology as part of the annual Forum for Research Ethics Committee Chairpersons.

September 8: Meeting of the Bioethics Collaborative. Topic: Ethics of Rare Diseases. For more information about the Bioethics Collaborative and how to join, click here.

September 9: 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.” International representatives will field questions related to EHDS challenges, areas of uncertainty, or provisions that remain unclear. This is the forum’s third convening, with additional events on EHDS implementation planned.

September 11, 11 AM – 12 PM ET: Framework for AI Adoption in Clinical Trials: A Case Study Perspective. Hosted by WCG, co-lead of the MRCT Center’s Artificial Intelligence (AI) and Ethical Research project, this webinar will explore how the MRCT Center’s Framework for Review of Clinical Research Involving Artificial Intelligence can be applied in real-world settings. Through a single, illustrative case study, panelists will discuss ethical and operational considerations, the role of human judgment, oversight responsibilities, and regulatory implications for AI in clinical trials. Participants will gain actionable insights to guide responsible AI adoption in research.

September 12, 11 AM – 12:00 PM ET: Continued Access to Investigational Products: Guiding Equitable and Fair Decisions. See webinar spotlight above for details.

September 14: Barbara Bierer will present a lecture on “Optimizing Representation in Clinical Research in an Interconnected, Global World” at the Second International Conference of the Japanese Association for Philosophical and Ethical Research in Medicine (JAPERM), held at Kanagawa University in Yokohama, Japan.

September 16: Barbara Bierer will present two talks, “Training and Professional Development of Research and Ethics Professionals” and “Patient and Public Involvement (PPI) in Advanced Cell and Regenerative Therapies,” to members of the RIKEN Institute, the premier Japanese research organization.

September 26-28: Barbara Bierer will open this year’s Society for Clinical Research Associates (SOCRA) conference in Chicago, IL, participating in the opening plenary panel entitled, “Research Advocacy Under a New Administration: Insights and Actions.” Sylvia Baedorf Kassis will deliver the closing plenary address. She will focus on strategies for prioritizing conference takeaways, lessons learned, and new resources to increase impact.

September 30, 11 AM – 12:30 PM ET: AI Digital Twins and Synthetic Data: Applications to Clinical Trials. See webinar spotlight above for details.

October 22, 8:00 – 5:00 PM ET: MRCT Center Annual Symposium. See spotlight above for details.

Publications

August 6: In an Accountability in Research article titled “Disparate data retention standards in biomedical research”, Barbara Bierer and Carolyn Lye, Minal Caron, Lauren Walsh, and Mark Barnes discuss disparate data retention standards for biomedical research. The article summarizes the divergent data retention standards set forth by federal agencies, grant programs, and research institutions, as well as other applicable requirements under law, contract, and policy. The authors also discuss the importance of data retention in the context of research professionalism, data sharing efforts, intellectual property issues, and research integrity challenges, and provide recommendations for both institutions and applicable federal agencies to streamline and clarify data retention standards.

MRCT Center Updates

Our team is growing! We are thrilled to announce that two new Research Assistants have joined the MRCT Center.

Blythe Chen, MPH, joined the MRCT Center as a Research Assistant II in July 2025. She supports the Reproductive Health project and the Representation in Research portfolio.

Before joining the Center, Blythe was a Graduate Research Assistant with the Long-Term Care Data Cooperative and a study on post-vaccine immune responses in a nursing home setting. She was also a Project Manager in the Kwon Lab at the Ragon Institute of MGH, MIT, and Harvard.

Blythe holds an MPH in Health Services from Brown University and a BA in English from the University of North Carolina-Chapel Hill.

Olchey Tchavyntchak joined the MRCT Center as a Research Assistant in July 2025. Olchey provides research support, coordination, and development of materials for several projects, including the MRCT Center’s work in Artificial Intelligence and Ethical Research, as well as the European Health Data Space.

Olchey graduated with honors from Colby College and received her Bachelor’s degree in Biology and American Studies in 2025. Through internships, coursework, and independent studies, Olchey developed a personal focus on the nexus between global health and clinical research innovation.

June 2025 Newsletter

In the Spotlight

Framework for Review of Clinical Research Involving Artificial Intelligence (AI)

As part of the MRCT Center’s AI and Ethical Research project, the Framework for Review of Clinical Research Involving AI was co-developed by the MRCT Center and WCG, in collaboration with a diverse, multi-stakeholder task force. This resource offers institutional review boards (IRBs) and other oversight entities a structured, practical approach to evaluating protocols that involve artificial intelligence in research with human participants. The framework addresses emerging ethical and regulatory challenges specific to AI—such as algorithmic bias, adaptive learning, data identifiability, and the need for human oversight—while aligning with foundational ethical principles and applicable U.S. regulations. Through tools including a decision tree for regulatory applicability, stage-specific review guidance, and targeted ethical considerations, the framework supports consistent, thorough review processes that protect participants and promote the responsible use of AI in clinical research.

Introducing TRACE: Trial Regulatory and Clinical Ethics Optimization

The TRACE project is a dynamic initiative to strengthen and streamline clinical trial regulatory and ethics systems across Africa.

The MRCT Center, as a member of TRACE’s Core Project Team and lead of the Capacity Building & Accreditation and Funding Models sub-teams, is working alongside the African Vaccine Regulatory Forum (AVAREF) and Garnet Partners, with funding support from the the Gates Foundation, to design and implement sustainable regulatory and ethics solutions.

Despite growing interest in African clinical research, sponsors still encounter unclear submission pathways, manual or outdated systems, redundant reviews, and unpredictable timelines, all barriers TRACE aims to eliminate.

The initiative’s initial focus on Rwanda, Tanzania, Zimbabwe, and Nigeria drives regulatory optimization, ethics systems strengthening, and regional capacity building to create transparent, predictable, and efficient review processes that attract more trials to the region.

Dr. Barbara Bierer has recently completed a series of country visits to support TRACE’s core priorities. Between April and June, she visited Nigeria, Rwanda, Zimbabwe (with Sarah White), and Tanzania. Working closely with national partners, these visits focused on assessing current national ethics review systems, introducing the WHO’s tool for benchmarking ethics oversight, and identifying collaborative long-term strategies for financial sustainability. By working directly with local stakeholders, TRACE is supporting country-led solutions that will evolve throughout the project and help align practices with global standards.

On-Demand Webinars and Resources

Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process
This on-demand webinar, presented on June 24, provided an overview of the MRCT Center’s Clinical Research Glossary—a plain-language reference defining 187 clinical research terms, with 30 new terms open for public comment through July 5. It detailed the feedback submission process to ensure accuracy and inclusivity and underscored the significance of this input in advancing adoption as a CDISC global standard, empowering participants to make informed decisions. The recording, presentation slides, and related materials are now available.

A Framework for AI Adoption and Oversight in Clinical Research
As discussed above, this on-demand webinar, also presented on June 24, introduces a structured framework to support institutional review boards and sponsors in the ethical oversight of clinical research protocols involving artificial intelligence. The webinar includes an overview of the framework’s development, key considerations for risk-benefit analysis, and practical tools to guide decision-making. The recording, presentation slides, and related materials are now available.

Patient-Centered Long-Term Follow-Up for Gene Therapies
This on-demand webinar, presented on June 26, examines the FDA’s recommendations for long-term safety monitoring of gene therapy recipients—recognizing both the transformative benefits and potential health risks—and highlights the critical need to design follow-up studies around patient needs and preferences to minimize burdens. Building on prior discussions of platform trials and registries, this webinar emphasizes strategies to reduce burden and enhance participant-centered practices. Perspectives include insights from a foundation tackling patient loss to follow-up, expertise on embedding patient-centric culture change into study design, and a patient advocate’s lived experience emphasizing the power of patient voices in shaping compassionate, sustainable LTFU frameworks. The recording, presentation slides, and related materials are now available.

Biannual Meeting of the Joint Task Force for Clinical Trial Competency
The slides and Executive Summary from the June 2 biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) are now available.

Topics:

Integrating JTF Competencies: Curriculum Design and Accreditation at Arizona State UniversityComprehensive 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

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. A detailed agenda with speakers and panels is forthcoming.

On Thursday morning, join a co-branded program with Vivli: “Data in Action: From Contribution to Impact”—also complimentary and open to all Symposium registrants.

Events & Presentations

June 10: FasterCures, in partnership with the MRCT Center, convened the most recent webinar in the Convergence Project series, “From Barriers to Breakthroughs: Funding, Resources, and Support to Improve Clinical Trial Access and Innovation,” 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 spoke about funding models, addressed participant costs and insurance challenges, and showcased sustainable, equitable partnership approaches. Meeting registrants will receive a summary of the webinar sessions via email from FasterCures/Milken in the coming weeks.

June 16-24: Dr. Barbara Bierer and Sarah White visited leadership and members of the Medicines Research Council of Zimbabwe (MRCZ) and the Medicines Control Authority of Zimbabwe (MCAZ) for the TRACE Project Benchmarking meetings. The four days of meetings took place at the MRCZ and MCAZ offices, and the office of the Ministry of Health and Child Care in Harare, Zimbabwe. From June 23-24, Dr. Barbara Bierer continued TRACE Project benchmarking visits to Dar es Salaam and Dodoma, Tanzania to meet with leadership and members of the National Institute for Medical Research (NIMR) and Tanzania Medicines and Medical Devices Authority (TMDA). The purpose of these benchmarking visits was to initiate baseline assessments of the operations and infrastructure of the national research ethics committee boards and offices, a process that each country will complete on its own. Dr. Bierer will return to Africa in late July to attend the TRACE Project in-person Core Committee meetings in Kigali, Rwanda.

See TRACE Spotlight above.

July 16: Lisa Koppelman will lead an interactive session at the iCAN 2025 Summit in Montreal (July 14–16) titled “Time for a Reboot: Updating the Including Young People in Research Toolkit.” Young people and adult stakeholders from clinical research and related fields will revisit the engagement model that underpins the toolkit. Afterward, participating youth may apply to join a reference group tasked with reviewing the updated tools, materials, and resources.

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.

July 24-25: The MRCT Center joins Innovative Therapies for Children and Adolescents with Cancer, the Children’s Oncology Group, and the Leukemia & Lymphoma Society to host an invitation-only workshop in Washington, DC, “Advancing Childhood Cancer Academic-Industry Collaborative Platform Trials.” Building on the October 2024 Advancing Pediatric Platform Trials workshop, participants will work together to accelerate academic-industry platform trial collaborations in pediatric oncology and bring safe, effective therapies to young people with cancer.

Publications

May 8: In the article “Benefits that Offset Research Risks and Burdens are Qualitatively Different,” published in The American Journal of Bioethics, Barbara Bierer joins co-authors Luke Gelinas and Benjamin C. Silverman to examine how indirect benefits offered to research participants (e.g., payments, access to medicines) differ fundamentally from direct benefits that justify risk. The authors argue that these categories of benefit must be conceptually and ethically distinguished in research design and review. Their commentary challenges current interpretations of benefit-risk assessment and calls for greater nuance in ethical review frameworks.

April 28: In the article “Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct,” published in the Journal of Law, Medicine & Ethics, co-authors Mark Barnes and Barbara Bierer examine the persistent challenges of jurisdictional ambiguity when research misconduct spans multiple institutions. Together with Leslie Thornton and Devin Cohen, they outline key gaps in current regulatory guidance and propose a framework for collaborative resolution that safeguards fairness and research integrity. The article calls for clearer delineation of institutional responsibilities and improved mechanisms for inter-institutional coordination in misconduct investigations.

April 21: “Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions,” published in the Journal of Law, Medicine & Ethics, co-authored by Barbara Bierer and Mark Barnes, as well as Nathaniel Jaffe, Minal Caron, and Lauren Walsh, analyzes nine instances in which defamation suits were employed to obstruct misconduct investigations. It summarizes the legal bases of such claims and key defenses (e.g., Strategic Lawsuit Against Public Participation, truth, opinion), then distills institutional best practices—from calibrated public disclosures to stringent confidentiality protocols—to protect both scientific integrity and institutional resilience.

MRCT Center Updates

The MRCT Center is thrilled to announce the appointments of Michael Lauer, Deputy Director for Extramural Research at the National Institutes of Health – Retired, and Andy Lee, Senior Vice President and Head of Global Clinical Trials Operations at Merck Research Laboratories – Retired, to the External Advisory Board of the MRCT Center.

The MRCT Center External Advisory Board provides constructive feedback relating to long-term strategic planning and vision as well as new programmatic initiatives, strategic partnerships, and existing projects. The board meets annually and brings outside perspectives to the Center, helps to maintain a global perspective and awareness, and supports the Center’s continued growth.

May 2025 Newsletter

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

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.

New Podcast Episode: Trials Beyond Borders: Clinical Trials in Latin America—Aligning Global Research with Local Realities

Podcast cover art for an episode focused on Trials Beyond Borders.

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

webinar graphic for the biannual global meeting of the JTF

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

webinar graphic for Clinical Research Glossary webinar focused on the Public Review process on June 24

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

webinar graphic for AI framework event on June 24

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

Webinar graphic for Patient-Centered Long-Term Follow-Up for Gene Therapies on June 26

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.

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.

April 2025 Newsletter

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

May 6: Innovative Approaches to Gene Therapy Long-Term Follow-Up – Leveraging Registries and Platform Trials

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

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

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 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 2^nd 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.

March 2025 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:

Embeddin g 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: Data Literacy in Clinical Research – Enhancing Trust and Transparency

Understanding what data is collected, how it is protected, and how it is used is essential for participant understanding and informed consent, achieved through clear communication.

Join us on April 3, 10–11 AM ET, as the MRCT Center and PHUSE unveil new resources—videos, infographics, and practical tools—to enhance data literacy for participants and research teams.

Click HERE to register

Webinar: Global Development of a Clinical Research Workforce: Tools and Resources

Join us on April 3, 9–10 AM ET, for a webinar on workforce development in clinical research. Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS), will deliver the keynote.

Panelists will explore the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundation for training and career development:

Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), on building a diverse and skilled workforce through education and collaborations.
Sally Armstrong, CEO of PRAXIS Australia, on integrating the JTF Framework into courses, workshops, and onsite training.

Click HERE to register

Webinar: Innovative Approaches to Gene Therapy Long-Term Follow-Up – Leveraging Registries and Platform Trials.

Join us on Tuesday, May 6, 1–2 PM ET, to discuss innovative approaches to long-term follow-up (LTFU) in gene therapy (GT). While GT offers transformative health benefits, long-term safety monitoring is essential, often spanning years or a lifetime. 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.

Click HERE to register

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.

Click HERE to register

Cognition Therapeutics is a new Steering Committee sponsor

We are delighted to announce that Cognition Therapeutics has joined the Steering Committee of the MRCT Center. Cognition Therapeutics is a clinical-stage biopharmaceutical company that is discovering and developing innovative, small-molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina.

To learn more about Cognition Therapeutics, click here.

To learn more about becoming an MRCT Center sponsor, click here

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.

MRCT Center News

Dr. Bierer Honored at 2025 Research!America Awards

Dr. Barbara Bierer, Faculty Director of the MRCT Center, was honored with the Herbert Pardes Family Award for National Leadership in Advocacy for Research at the 2025 Research!America Advocacy Awards on March 12. This prestigious award recognizes her dedication to advancing research, including clinical research, ethics, policy, and global collaboration.

February 2025 Newsletter

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.

Data Literacy in Clinical Research: Enhancing Trust and Transparency

A key aspect of health literacy—especially in clinical research—is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.

The MRCT Center, in collaboration with PHUSE, has developed a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar on April 3 from 10 – 11 AM ET as we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.

Key Topics:

Advancing Data Literacy as a Component of Health Literacy

Applying Plain Language and Visual Tools to Data Communication

Empowering Participants with Transparent and Actionable Information.

Click HERE to register

Webinar: Global Development of a Clinical Research Workforce: Tools and Resources

Join us on April 3 from 9 – 10 AM ET 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.

Click HERE to register

The MRCT Center works to improve the integrity, safety, and rigor of global clinical research by shaping policies that foster ethical, responsible, and accessible research practices. Contributing to policy engagement and public dissemination by submitting public commentary on regulatory proposals, draft guidance, and policies ensures that evolving frameworks, guidelines, and rules reflect the needs of research participants, sponsors, investigators, and the broader scientific community. Our ongoing engagement demonstrates our dedication to strengthening research integrity through thoughtful feedback on evolving regulations, promoting participant protection and ethical considerations, and encouraging innovation and practical implementation.

Since January 2024, we have submitted 27 public comments, shaping policies and practices that impact sponsors, researchers, and participants worldwide. These contributions help ensure that research remains rigorous, responsible, and accessible.

Examples of Our Recent Public Comments:

Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics (February 4, 2025): We suggested clarifications on surrogate endpoint validation, confirmatory trial rigor, expanded public disclosures, decision-making transparency, and global considerations in the absence of international harmonization.
Ethical Guidelines for Research Using Pervasive Data (January 15, 2025): We advocated for enhanced safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address advancements and mitigate risks to individuals and communities.
Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice (December 13, 2024): Our comments focused on data quality when using clinical 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.
Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons (November 29, 2024): We emphasized the need to balance 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 the advancement of science, medicine, and individual and public health.

Click here to explore all the MRCT Center’s Public Comments.

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.

January 2025 Newsletter

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.

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!

Click HERE to register

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

Click HERE to register

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.

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.

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.