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.
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.
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.
Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-2402
Description: The MRCT Center’s public comments on the FDA’s draft guidance, Considerations for Including Tissue Biopsies in Clinical Trials, 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.
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.
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.
This webinar was co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group as a part of their 5th Annual Lunchtime Learning Series. The panel on Long-Term Follow-Up (LTFU) was moderated by Dr. Carolyn Chapman and captured the ethical, regulatory, and operational challenges of LTFU studies through diverse viewpoints and perspectives.
Comments provided to: Chief Counsel, National Telecommunications and Information Administration
Description: 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 that recommends 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.
