Introduction
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. It is accompanied by a Toolkit, including checklists, logic models and case studies, a metrics framework Equity by Design, and resources to support ethics committees. All these are living documents, and further work on specific aspects of what is now known as Diversity, Equity, and Inclusion (DEI), such as inclusion of people with disabilities in clinical research, is ongoing.
It is in this continued exploration of specific aspects of DEI that the MRCT center has begun a project on Global DEI. 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. 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.
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.
The preliminary scoping of the first objective 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; divergent approaches of regulators worldwide regarding diversified participation in research, both in terms of licensing requirements and the endorsement of best practices; and varying motivations for addressing DEI at a global level, ranging from ethical considerations regarding broader generalizability and global access to interventions to more immediate needs for compliance with regulatory mandates in different regions.
In essence, the project seeks to synthesize these multifaceted elements into a unified strategy that addresses DEIA challenges in the global clinical research landscape.
We have been drafting four principal tools:
- A Draft Roadmap: Prompts for Developing a global diversity, equity, inclusion, and accessibility (DEI) strategy
- Embedding Ethical Considerations related to global DEI
- Working with Partner Countries to Strengthen Research Capacity
- Diversity Action Plan (DAP) Template
The MRCT Center introduced and discussed the draft Roadmap and Ethics tools during the [invite-only] EC/SC meeting in December. Additionally, the Diversity Action Plan (DAP) tool was presented at the [public] MRCT Annual meeting, which took place in December 2023.