The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, first released in August 2020, outlines a principled, multi-stakeholder approach to optimize the inclusion of diverse populations in clinical research.
The Guidance Document developed as a result of, first, a May 2017 MRCT Center Bioethics Collaborative and, second, the efforts of a workgroup composed of approximately 50 representatives of industry, academia, patients and patient advocates, regulatory authorities, clinical research organizations, and other entities.
The workgroup endeavored to explore why diverse representation has not increased despite evidence of the problem; identify and analyze barriers that limit diverse participation, and to develop and disseminate resources such as guidance materials, tactical strategies, and tools to advance required changes to conceptual, organizational, and operational challenges. The result is this guidance, a living document, one that will expand and grow. We hope this work inspires innovation and forward momentum to achieve diversity, inclusion, and equity in clinical research. We invite readers to engage with us to enhance the document, resources, tools, and case studies.
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This work began at an MRCT Center Bioethics Collaborative, a neutral forum during which a number of clinical research stakeholders convened to discuss diversity in clinical trials. The attendees of that meeting, represented by a multi-stakeholder group of industry, academia, government, and patient advocacy, agreed that the participant population enrolled in a clinical trial ought to be representative of the general population at a minimum and, optimally, of the intended population for the intervention. If study populations are skewed, if they lack diversity, then the safety and efficacy, effectiveness, and value of medical interventions—the biological heterogeneity of treatment effect— cannot..Read More
The 50+ member workgroup for this project began regularly meeting in 2018.
The comments submitted were in response to draft guidance on enhancing the diversity of clinical trial populations, which had been published by FDA in June, 2019.
Official release of Achieving Diversity, Inclusion, and Equity in Clinical Research, a Guidance Document with an accompanying Toolkit.
FDA Office of Minority Health and Health Equity hosted the public launch for Achieving Diversity, Inclusion, and Equity in Clinical Research.
This webinar series focused on practical approaches and shared experiences for improving diversity in clinical research. Seven webinar sessions were held, featuring a diverse group of guest speakers.
In collaboration with FDA, the MRCT Center hosted ‘Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations.’ More than 30 speakers and 250 guests participated in the three day conference, which was recorded and is available online.
MRCT Center updated the Diversity in Clinical Research Website to include user-friendly options to explore the Guidance Document and Toolkit.
Launch of the second webinar series ‘Driving Inclusion in Clinical Research’ to focus on how to approach and plan for inclusion, implement recommendations, and sustain progress. Registration is open and available online.
Change and corrective action are challenging and will only occur with the commitment of the entire clinical research enterprise. In the service of science, equity, and public health, we call on all stakeholders to do more, to address the inequity, and to advance the understanding of biological diversity in medicine.