About this Work

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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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.