Focus Area: Clinical Trials & Research

Introduction

The MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, released in late 2020 and updated in 2021, 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, an Equity by Design metrics framework, and resources to support ethics committees. These are all living documents, and further work, such as the inclusion of people with disabilities in clinical research, is ongoing.

As part of this further work, the MRCT Center has widened our DEI lens from domestic to Global Representation. Over the last nine months, we have collaboratively sought 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. We have several tools under development, including a draft Roadmap (prompts for developing a global diversity, equity, inclusion, and accessibility strategy) introduced during the [invite-only] Executive and Steering Committees meeting in December and a Diversity Action Plan (DAP) tool presented at the MRCT Annual Meeting.  

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.

1. 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.
2. 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 DEI 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

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