Description: New requirements for clinical trial sponsors to submit diversity action plans to the US Food and Drug Administration (FDA) are an important step to embed planning for diverse representation in clinical trial research. These must not, however, be implemented in ways that are detrimental to other countries’ health and research interests. It is possible for those making operational decisions on country and site selection to address the needs of underserved populations in other countries at the same time as meeting US regulatory expectations — for example, by addressing barriers to diverse recruitment. Site selection should follow purposeful engagement in the local and regional culture, considering the needs of the local population, and proceed only if the trial is responsive to those needs.
Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. Despite recent legislative efforts to improve diversity in clinical trials, and many individual organizational efforts, a national plan to include diverse patients does not exist.
Please note, the 4th [hybrid] meeting in this series, entitled “Toward a Framework to Improve Diversity and Inclusion in Clinical Trials,” will be hosted by NASEM in Washington DC on May 20. You can find out more information and register here. This workshop will build on the National Action Plan. We will be focusing on commitment to strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.
Comments provided to: U.S. Food and Drug Administration
The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219). In broad strokes, our comments recommended expanded guidance on the role Data Monitoring Committees can play in actively fostering the safety of trial participants – whether by communicating directly with trial sponsors, IRBs, or with offices within FDA. We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA. As with all our interactions with the FDA, we commend their commitment to setting the global pace when it comes to ensuring the conduct of scientifically sound, risk appropriate, ethical clinical research.
The MRCT Center submitted a response to a draft ethics charter intended to protect healthy volunteers in clinical trials published by the French National Institute of Health and Medical Research (“INSERM”). The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. Broadly, the MRCT Center wholly supports the development of an ethical charter to protect healthy trial participants. Our comments reflected our support for the broader endeavor while remaining dedicated to helping INSERM craft language that reflects their well-intentioned goal.
Abstract:In the checklist below, the MRCT Center provides recommendations for the use of language that is respectful to and inclusive of LGBTQIA+ populations. The checklist can be used by stakeholders across the clinical research spectrum, from sponsors to patient navigators, when creating participant-facing documents (e.g., recruitment materials, informed consent forms), drafting study protocol eligibility criteria, and speaking with participants face-to-face. It is our shared responsibility to listen to participants’ and communities’ choice of wording and address, continually learn from each other, and ensure that all eligible people are encouraged to participate by the language that we use.
Abstract:Each of us feels more welcome to participate in a clinical trial if we see ourselves represented in the visual information communicated about the study, study site/s, and study staff. In the case study below, we illustrate how the MRCT Center worked to build LGBTQIA+ representation into the imagery that was developed for a specific product, the Clinical Research Glossary. The tool shares lessons learned by the MRCT Center based on insights and comments shared by the LGBTQIA+ Inclusion by Design in Clinical Research working group and mock-ups of two of the resulting images.
