Toward a Framework to Improve Diversity and Inclusion in Clinical Trials

Despite decades of ongoing efforts to improve racial and ethnic diversity in clinical trials, many gaps remain in achieving demographic representation in clinical studies. In May 2024, the National Academies Forum on Drug Discovery, Development, and Translation, in collaboration with the National Cancer Policy Forum, hosted a public workshop to explore system-level changes and initiatives across organizations and sectors to improve representation, data collection, and reporting in clinical trials and progress tracking in the United States.

Table of Contents

Front Matter 1 Introduction 2 Community Engagement and Investment 3 Defining, Collecting, and Sharing Comprehensive and Consistent Data on Trial Diversity 4 Clinical Trial Site Enablement 5 Agency Perspectives: CMS, FDA, and NIH 6 Challenging the Clinical Trial Ecosystem References Appendix A: Workshop Agenda Appendix B: Biographical Sketches of the Workshop Planning Committee and Speakers