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Review
. 2022 May:116:106740.
doi: 10.1016/j.cct.2022.106740. Epub 2022 Mar 29.

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

Michelle D Kelsey  1 , Bray Patrick-Lake  2 , Raolat Abdulai  3 , Uli C Broedl  4 , Adam Brown  5 , Elizabeth Cohn  6 , Lesley H Curtis  7 , Chris Komelasky  8 , Michael Mbagwu  9 , George A Mensah  10 , Robert J Mentz  1 , Amesika Nyaku  11 , Stephanie O Omokaro  12 , Judy Sewards  13 , Kendal Whitlock  4 , Xinzhi Zhang  14 , Gerald S Bloomfield  15
Affiliations
Review

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

Michelle D Kelsey et al. Contemp Clin Trials. 2022 May.

Abstract

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.

Keywords: Clinical trials; Diversity; Inclusion; Underrepresented populations.

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Conflict of interest statement

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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