journal article Open Access Dec 15, 2022

Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone

Abstract
Healthcare disparities are a persistent societal problem. One of the contributing factors to this status quo is the lack of diversity and representativeness of research efforts, which result in nongeneralizable evidence that, in turn, provides suboptimal means to enable the best possible outcomes at the individual level. There are several strategies that research teams can adopt to improve the diversity, equity, and inclusion (DEI) of their efforts; these strategies span the totality of the research path, from initial design to the shepherding of clinical data through a potential regulatory process. These strategies include more intentionality and DEI‐based goal‐setting, more diverse research and leadership teams, better community engagement to set study goals and approaches, better tailored outreach interventions, decentralization of study procedures and incorporation of innovative technology for more flexible data collection, and self‐surveillance to identify and prevent biases. Within their remit of overlooking research efforts, regulatory authorities, as stakeholders, also have the potential for a positive effect on the DEI of emerging clinical evidence. All these are implementable tools and mechanisms that can make study participation more approachable to diverse communities, and ultimately generate evidence that is more generalizable and a conduit for better outcomes. The research community has an imperative to make DEI principles key foundational aspects in study conduct in order to pursue better personalized medicine for diverse patient populations.
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References
71
[5]
Centers for Disease Control and Prevention.Diabetes. Advancing Health Equity<https://www.cdc.gov/diabetes/disparities.html> (2021). Accessed August 14 2022.
[12]
World Health Organization (WHO).Health Topics. Health Equity<https://www.who.int/health‐topics/health‐equity#tab=tab_1> (2022). Accessed August 14 2022.
[13]
United States Renal Data System (USRDS).2021 USRDS Annual Data Report<https://adr.usrds.org/2021> (2021). Accessed September 7 2022.
[29]
National Academies of Sciences, Engineering, and Medicine (2022)
[30]
National Academies of Sciences, Engineering, and Medicine (2022)
[40]
National Institutes of Health.All of Us Research Program<https://allofus.nih.gov/news‐events/press‐kit/all‐us‐research‐program‐backgrounder> (2022). Accessed August 16 2022.
[41]
The All of Us Research Program: Data quality, utility, and diversity

Andrea H. Ramirez, Lina Sulieman, David J. Schlueter et al.

Patterns 10.1016/j.patter.2022.100570
[43]
The HERO (Healthcare Worker Exposure Response & Outcomes) program<https://heroesresearch.org/> (2021). Accessed August 16 2022.
[47]
Arora J. "Connecting real‐world data to support public health efforts" NEJM Catal. Innov. Care Deliv. (2022)
[48]
International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use.ICH harmonised guideline: general considerations for clinical studies E8(R1)<https://database.ich.org/sites/default/files/E8‐R1_Guideline_Step4_2022_0204%20%281%29.pdf> (2021). Accessed September 6 2022.
[49]
US Food and Drug Administration.Collection of Race and Ethnicity Data in Clinical Trials. Guidance for Industry and Food & Drug Administration Staff<https://www.fda.gov/media/75453/download> (2016). Accessed August 28 2022.
[50]
Pharmaceutical and Medical Devices Agency (PMDA).Basic Principles on Global Trials. Notification No. 0928010<www.pmda.go.jp/files/000157900.pdf> (2007). Accessed August 28 2022.

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Details
Published
Dec 15, 2022
Vol/Issue
113(3)
Pages
575-584
License
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Cite This Article
Vindell Washington, Joseph B. Franklin, Erich S. Huang, et al. (2022). Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone. Clinical Pharmacology &amp; Therapeutics, 113(3), 575-584. https://doi.org/10.1002/cpt.2804