Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.

Journal Article (Journal Article;Review)

BACKGROUND: Improving diversity in clinical trials is essential in order to produce generalizable results. Although the importance of representation has become increasingly recognized, identifying strategies to approach this work remains elusive. This article reviews the proceedings of a multi-stakeholder conference about the current state of diversity in clinical trials and outlines actionable steps for improvement. METHODS: Conference attendees included representatives from the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), practicing clinical investigators, pharmaceutical and device companies, community-based organizations, data analytics companies, and patient advocacy groups. At this virtual event, attendees were asked to consider key questions around best practices for engagement of underrepresented populations. RESULTS: Community engagement is an integral part of recruitment and retention of underrepresented groups. Decentralization of sites and use of digital tools can enhance the accessibility of clinical research. Finally, improving representation among investigators and clinical research staff may translate to diverse clinical trial participants. CONCLUSION: Improving diversity in clinical trials is an ethical and scientific imperative, which requires a multifaceted approach.

Full Text

Duke Authors

Cited Authors

  • Kelsey, MD; Patrick-Lake, B; Abdulai, R; Broedl, UC; Brown, A; Cohn, E; Curtis, LH; Komelasky, C; Mbagwu, M; Mensah, GA; Mentz, RJ; Nyaku, A; Omokaro, SO; Sewards, J; Whitlock, K; Zhang, X; Bloomfield, GS

Published Date

  • May 2022

Published In

Volume / Issue

  • 116 /

Start / End Page

  • 106740 -

PubMed ID

  • 35364292

Pubmed Central ID

  • PMC9133187

Electronic International Standard Serial Number (EISSN)

  • 1559-2030

Digital Object Identifier (DOI)

  • 10.1016/j.cct.2022.106740


  • eng

Conference Location

  • United States