The MRCT Center, on behalf of the Convergence Project hosted a virtual event focused on workforce development strategies to support a more dynamic and competitive clinical research workforce. This meeting brought 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 included workforce development, targeted recruitment, and actionable steps to drive systemic improvements, and meeting attendees had the opportunity to pose questions to panelists leading programs in Georgia, North Carolina, South Dakota, and other states across the country.
Capacity strengthening is vital to ensure that countries—particularly those with limited resources—can conduct effective, high-quality clinical research. The ability to perform rigorous trials is often constrained by inadequate infrastructure, regulatory processes, and a lack of trained researchers. As noted by the Science for Africa Foundation, despite accounting for over 25% of the global disease burden, Africa hosts only about 4% of global clinical trials. To address these gaps, supporting locally-driven capacity-building initiatives is key. This involves collaborating with national health departments, research institutions, and local communities to create sustainable, long-term systems that enhance both healthcare and research capabilities.
Capacity-building efforts can be approached at three levels: individual, organizational, and national. These include fostering researcher skills, improving research infrastructure, and strengthening the national regulatory environment. It is essential to work with local stakeholders to identify needs and design solutions that will be effective long term. For example, external funders can support training opportunities for local researchers, enhance regional collaboration, and promote community engagement to raise awareness of clinical research. By taking a comprehensive, staged approach to capacity strengthening, we can build resilient research systems that ultimately lead to more inclusive healthcare innovation and a more equitable global research landscape.
Embedding Ethical Considerations Relating to Global Representation in Clinical Research offers a thorough exploration of the ethical issues surrounding global representation in clinical trials. Central to the document is the ethical imperative to ensure that clinical research reflects the populations most affected by the diseases being studied while addressing the systematic inequalities that limit access to participation. The guide raises key ethical questions: Are the right groups being included in the research? How can we ensure that participants will benefit from the outcomes, both during and after the study? How are diverse populations, particularly in low-resource settings, engaged ethically and without exploitation?
This document also provides a valuable framework for study sponsors and research teams, offering a series of ethical considerations and questions that should be addressed throughout the study process. These considerations include the need for thoughtful engagement with local communities, careful assessment of barriers to participation, and strategies to reduce the risk of exploitation or undue inducement. By documenting their responses to these ethical questions, sponsors and study teams can ensure that their studies are conducted with integrity, fairness, and respect for all participants, helping to create research that is not only scientifically valid but also ethically sound and globally representative.
Please join us on Tuesday, May 6, from 1-2 pm ET for a webinar that will explore different approaches for realizing Gene Therapy (GT) Long-Term Follow-Up (LTFU). GTs have the potential for long-lasting and transformative health benefits, but there are also long-term health risks. Therefore, the FDA recommends long-term safety monitoring of recipients of certain types of GTs. As these LTFU studies can last years (even up to a lifetime), they pose significant scientific and logistical challenges. We are grateful for our three distinguished panelists, who will discuss innovative approaches for GT LTFU.
Dr. Barbara Konkle, a hematologist at the Washington Center for Bleeding Disorders, Professor of Medicine Emeritus in Hematology-Oncology at the University of Washington, and the Medical Director of the Bleeding Disorders Laboratory at Bloodworks NW, will share information about the goals and development of the World Federation of Hemophilia’s Gene Therapy Registry (GTR). The GTR is a prospective, observational, and longitudinal registry designed to collect long-term data on people with hemophilia who receive GT.
Dr. Amy Moskop isan Assistant Professor in the Department of Pediatrics and the Division of Hematology/Oncology/BMT at the Medical College of Wisconsin and the Scientific Director of the Gene Therapy Program at the Center for International Blood and Marrow Transplant Research (CIBMTR). Dr. Moskop will provide an overview of the CIBMTRregistry and its intersection with GT LTFU.
Dr. Avery McIntosh, Director, Biostatistics, Internal Medicine and Infectious Disease at Pfizer, will share practical considerations for GT LTFU safety studies and provide an overview of the potential benefits of platform and master protocol approaches. Dr. McIntosh has co-authored a paper on this topic, published in 2024 (doi:10.1002/cpt.3087). He has co-edited a book, Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations, also published last year.
Dr. Carolyn Riley Chapman, who leads the Cell and Gene Therapies project at the MRCT Center, will moderate.
Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-4245
Description: The MRCT Center commented on the FDA’s draft guidance, Study of Sex Differences in the Clinical Evaluations of Medical Products, 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.
Abstract: 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: Volume 25 Issue 2, in January 2025. The print publication of this article, which was initially published online in November 2023, was accompanied by 15 Open Peer Commentaries and one Editorial. In March, AJOB published an open-access reply to the commentaries titled “Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research.” In the reply, Dr. Chapman and colleagues noted that their main goal with the Target Article was to generate discussion about what, if anything, should be done to ethically manage the potential for group harm in data-centric research; they thanked the commentators for their engagement with the issue. “Wanted, but Elusive” reviews key points in the articles, highlights common themes, and weighs recommendations and next steps.
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 and PHUSE are collaborating to develop a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar 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
Explore how understanding research data supports informed decision-making and aligns with broader health literacy efforts.
Applying Plain Language and Visual Tools to Data Communication
Learn how the MRCT Center and PHUSE have used plain language and infographics to make clinical research data more accessible.
Empowering Participants with Transparent and Actionable Information
Identify ways to integrate data literacy resources into your clinical research processes to support research trust and engagement.
Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited?
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Submitted to: Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
The MRCT Center submitted public comments in response to 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.
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.
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!
