Comments provided to: National Institutes of Health
Abstract: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.
The first podcast in our new series, “Trials Beyond Borders: Building Representative Clinical Trials Worldwide.” The podcast features a conversation with MRCT Center Program Director Willyanne DeCormier Plosky and Tinaya Gray, a consultant with ICON plc, focusing on communications between sponsors, CROs, and sites in planning for diversity action plans in the context of global trials.
The Model Diversity Action Plan (DAP) was developed in response to the FDA’s latest directive aimed at improving diversity within clinical trial participation. Built upon the MRCT Center’s Recruitment Strategy Document, this framework supports compliance with FDA standards. The Model DAP also outlines clear objectives that extend beyond the FDA’s initial guidelines, emphasizing a broader international viewpoint. Sponsors are encouraged to delineate specific regions and countries targeted for trial inclusion, detailing proactive strategies designed to overcome obstacles related to diverse, inclusive, and equitable recruitment practices, particularly outside the United States. While these additional details may not always be mandatory for FDA submissions, they are pivotal in fostering a comprehensive approach to trial design and execution. Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion. This dynamic document will evolve as the FDA guidance is finalized.
The Global Representation Roadmap provides a structured approach for stakeholders to define and implement DEI strategies across their global clinical research portfolios. It guides organizations through a seven-stage process tailored to account for varying dimensions of DEI across different countries and contexts. Key focuses include clarifying organizational DEI objectives, defining epidemiology by therapeutic area in target countries, and considering ethical implications in site selection. The Global Representation roadmap prompts stakeholders to address country-specific regulatory requirements related to diversity and outlines minimum actions in their absence. It advocates for proactive DEI targets and capacity-building initiatives, while emphasizing ongoing community engagement and accountability through periodic ethics checkpoints. Additionally, it encourages the use of program-specific Diversity Action Plans to enhance recruitment effectiveness and ensure continuous improvement and transparency in Global Representation efforts.
Comments provided to: National Institutes of Health
Description: The MRCT Center submitted public comments on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with the communities where they intend to conduct research prior to, during, and after the research. Researchers should cultivate bi-directional partnerships with the communities, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response.
Comments provided to: National Institutes of Health
Description: We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences.
This meeting was presented to the Bioethics Collaborative. The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
Abstract:It is generally agreed that sponsors and other entities undertaking research in limited-resource settings incur certain duties of reciprocity. These obligations ensure that host communities are treated fairly and not exploited, given the burdens and risks of research undertaken by community members. However, the expectations, content, and limitations of these obligations are not defined. The next Bioethics Collaborative will be devoted to understanding and assessing different approaches to satisfying the ethical contorts of reciprocity for research undertaken in these settings.
Comments provided to: National Institutes of Health (NIH) Office of Science Policy (OSP)
Description: The MRCT Center recommended that NIH OSP (1) clarify and expand on the methods to promote equitable access, (2) consider greater flexibility in the application of this policy to investigational products, and (3) require direct engagement with community stakeholders and patient advocacy groups when NIH assesses the impact of the policy.
Comments provided to: Office of Science and Technology Policy
The MRCT Center submitted public comments on the White House Office of Science and Technology Policy (OSTP) Request for Information entitled, “Federal Evidence Agenda on Disability Equity,” published at 89 Fed. Reg. 46924 (May 30, 2024). The collection of reliable disability data remains a challenge to researchers, and we applaud the OSTP’s commitment to measurements of health equity that is inclusive of people with disabilities. We share OSTP’s vision for bringing disability data to the foreground and your enthusiasm for understanding where and how best to include questions on disability. In our comments, we focused on information that would be helpful for the understanding of healthcare, health disparities, and clinical research and refrained from commenting on specific survey methodology used in federal and international data collection that is beyond our area of expertise. The MRCT Center pointed the OSTP to standard practices standard practices to safeguard privacy and security, as outlined by federal policy (HIPAA, OHRP, FDA, DOD, NIH, and others) that include a management plan for secure storage and transfer of data throughout the life cycle of the project; communicating clearly with participants when, why, and how disability data will be collected and used; always providing an option for participants to opt-out of answering any or all disability data questions; and only making disability data available [to research teams] through a controlled access environment. We advocate for plain language, logical reading order, the ability to easily go back and correct answers, and the provision of reasonable accommodations during the informed consent process and in any survey/measurement instrument (whether in print, on a computer, or mobile device). Finally, we note that for any form of disability data collection, people with disabilities must first be asked to participate, and that barriers such as inappropriately restrictive screening criteria should be eliminated.
