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. However, while many aspects of the Guidance Document and tools are relevant and applicable outside the US context, they nevertheless privilege US-centric perspectives and regulatory requirements.
The preliminary scoping for the project has brought to light several areas of focus encompassing: the recognition that different dimensions of diversity hold varying degrees of relevance in diverse global contexts; the challenges of categorizing diversity facets like race, ethnicity, and social determinants of health in ways that remain contextually meaningful in various countries; ethical concerns related to incentivizing the participation of groups traditionally viewed as ‘vulnerable’ in research, along with associated risks of exploitation; and divergent approaches of regulators worldwide regarding diversified participation in research.
The primary objectives of this project encompass a comprehensive exploration of DEI challenges within the domain of global clinical research. These objectives are two-fold.
- The project is focused on a deeper comprehension of DEI issues in clinical research on a global scale. This entails seeking insights from key stakeholders such as sponsors, regulators, ethics committees, health departments, Principal Investigators (PIs), study sites, and research participants.
- The project is working on enhancing and expanding the existing resources and tools provided by the MRCT Center to incorporate these broader perspectives. This expansion includes supporting DEI in research endeavors within individual countries and, notably, in multi-country studies.
Further work is required to better understand how concerns around diversity, equity, and inclusion in clinical research are understood and prioritized in different countries and regions around the world, and what this means for the many stakeholders involved in research conducted in multi-country contexts.
Related Assets
- Global Representation Roadmap: Prompts for Developing a global diversity, equity, inclusion, and accessibility (DEI) strategy
- Model Diversity Action Plan (DAP)
- “Trials Beyond Borders” podcast
- Coming soon: Embedding Ethical Considerations Related to Global DEI
- Coming soon: Working with Partner Countries to Strengthen Research Capacity
- First, do no harm: a global perspective on diversity and inclusion in clinical trials
Please note: The tools listed above are living documents and will be improved with use. We welcome feedback, suggestions, useful references, resources, and concerns.
Acknowledgments
Many thanks to everyone who has so thoughtfully collaborated on these projects. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed in project materials are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work.
Leadership team
- Dr. Barbara Bierer, Faculty Director, MRCT Center
- Hayat Ahmed, Program Manager, MRCT Center
- Dr. Willyanne DeCormier Plosky (she/her/hers), Program Director, MRCT Center
- Katharine White, Consultant
Reviewers (DAP Model and Roadmap)
Reviewers (capacity strengthening and ethical considerations)
Subject matter experts involved in other capacities
