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

被引：90

作者：

Kelsey, Michelle D. ^{[1
,2
]}

Patrick-Lake, Bray ^{[3
]}

Abdulai, Raolat ^{[4
]}

Broedl, Uli C. ^{[5
]}

Brown, Adam ^{[6
]}

Cohn, Elizabeth ^{[7
]}

Curtis, Lesley H. ^{[2
,8
]}

Komelasky, Chris ^{[9
]}

Mbagwu, Michael ^{[10
]}

Mensah, George A. ^{[11
]}

Mentz, Robert J. ^{[1
,2
]}

Nyaku, Amesika ^{[12
]}

Omokaro, Stephanie O. ^{[13
]}

Sewards, Judy ^{[14
]}

Whitlock, Kendal ^{[5
]}

Zhang, Xinzhi ^{[15
]}

Bloomfield, Gerald S. ^{[1
,2
]}

机构：

[1] Duke Univ, Dept Med, Div Cardiol, Durham, NC USA

[2] Duke Clin Res Inst, Durham, NC USA

[3] Evidat Hlth Inc, San Mateo, CA USA

[4] Sanofi, Cambridge, MA USA

[5] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany

[6] ClinArk, Dayton, OH USA

[7] CUNY, Hunter Coll, New York, NY 10021 USA

[8] Duke Univ, Sch Med, Dept Populat Hlth Sci, Durham, NC USA

[9] SiteBridge, Chapel Hill, NC USA

[10] Verana Hlth, San Francisco, CA USA

[11] NHLBI, NIH, Bethesda, MD USA

[12] Rutgers New Jersey Med Sch, Dept Med, Div Infect Dis, Newark, NJ USA

[13] US FDA, Silver Spring, MD USA

[14] Pfizer Inc, New York, NY USA

[15] Natl Inst Minor Hlth & Hlth Dispar, NIH, Bethesda, MD USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2022年 / 116卷

关键词：

Diversity; Inclusion; Underrepresented populations; Clinical trials; MINORITIES; BARRIERS; CANCER; PARTICIPATION; FACILITATORS; RECRUITMENT; POPULATIONS; RETENTION; ETHNICITY; LITERACY;

D O I：

10.1016/j.cct.2022.106740

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：5

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