Global populations/People living outside the US

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) first released the Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, in August 2020. This document outlines a principled, multi-stakeholder approach designed to optimize the inclusion of representative populations in clinical research. While many aspects of the Guidance Document and tools are applicable globally, they tend to reflect US-centric perspectives and regulatory requirements.

Initial scoping identified key focus areas: the relevance of different aspects of representation across global contexts, the challenge of meaningfully categorizing race, ethnicity, and social determinants of health, ethical concerns around incentivizing participation from marginalized groups, and the varying regulatory approaches to promoting inclusive clinical research.

This project has two main objectives:

1. Deepening the understanding of representation issues in multi-regional research. This involves gathering insights from key stakeholders, including sponsors, regulators, ethics committees, health departments, principal investigators (PIs), study sites, and research participants.
   
   
2. Enhancing and broadening the MRCT center’s existing tools to incorporate a wider range of global perspectives. This includes supporting representative participation in both country-specific and multi-country research studies.

Further work is required to better understand how the concepts of representation, inclusion, and equity are prioritized and addressed across different countries and regions, and how these priorities shape research 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.

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