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

Publication ,  Journal Article
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 ...
Published in: Contemp Clin Trials
May 2022

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.

Duke Scholars

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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

May 2022

Volume

116

Start / End Page

106740

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Research Personnel
  • Public Health
  • Humans
  • General Clinical Medicine
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 11 Medical and Health Sciences
 

Citation

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Kelsey, M. D., Patrick-Lake, B., Abdulai, R., Broedl, U. C., Brown, A., Cohn, E., … Bloomfield, G. S. (2022). Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials, 116, 106740. https://doi.org/10.1016/j.cct.2022.106740
Kelsey, Michelle D., Bray Patrick-Lake, Raolat Abdulai, Uli C. Broedl, Adam Brown, Elizabeth Cohn, Lesley H. Curtis, et al. “Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.Contemp Clin Trials 116 (May 2022): 106740. https://doi.org/10.1016/j.cct.2022.106740.
Kelsey MD, Patrick-Lake B, Abdulai R, Broedl UC, Brown A, Cohn E, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022 May;116:106740.
Kelsey, Michelle D., et al. “Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.Contemp Clin Trials, vol. 116, May 2022, p. 106740. Pubmed, doi:10.1016/j.cct.2022.106740.
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. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022 May;116:106740.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

May 2022

Volume

116

Start / End Page

106740

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Research Personnel
  • Public Health
  • Humans
  • General Clinical Medicine
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 11 Medical and Health Sciences