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. 2023 Dec;10(6):3140-3149.
doi: 10.1007/s40615-022-01487-0. Epub 2022 Dec 19.

A Systematic Review on Participant Diversity in Clinical Trials-Have We Made Progress for the Management of Obesity and Its Metabolic Sequelae in Diet, Drug, and Surgical Trials

Crystal N Johnson-Mann  1   2 , Julie S Cupka  3   4 , Alexandra Ro  3   4 , Andrea E Davidson  3   4 , Brooke A Armfield  3 , Frank Miralles  5 , Asena Markal  5 , Kiara E Fierman  3   4 , Victoria Hough  3   4 , Mackenzie Newsom  3   4 , Isha Verma  3   4 , Abdul-Vehab Dozic  3   4 , Azra Bihorac  3   4
Affiliations

A Systematic Review on Participant Diversity in Clinical Trials-Have We Made Progress for the Management of Obesity and Its Metabolic Sequelae in Diet, Drug, and Surgical Trials

Crystal N Johnson-Mann et al. J Racial Ethn Health Disparities. 2023 Dec.

Abstract

Objective: Individuals from Black and Hispanic backgrounds represent a minority of the overall US population, yet are the populations most affected by the disease of obesity and its comorbid conditions. Black and Hispanic individuals remain underrepresented among participants in obesity clinical trials, despite the mandate by the National Institutes of Health (NIH) Revitalization Act of 1993. This systematic review evaluates the racial, ethnic, and gender diversity of clinical trials focused on obesity at a national level.

Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic review of clinicaltrials.gov, PubMed, Cochrane Central, and Web of Science was undertaken to locate phase 3 and phase 4 clinical trials on the topic of obesity that met associated inclusion/exclusion criteria. Ultimately, 18 studies were included for review.

Results: White non-Hispanic individuals represented the majority of clinical trial participants, as did females. No study classified participants by gender identity. Reporting of race/ethnicity was not uniform, with noted variability among racial/ethnic subgroups.

Conclusions: Our findings suggest that disparities remain in the diverse racial, ethnic, and gender representation of participants engaged in clinical trials on obesity relative to the prevalence of obesity in underrepresented populations. Commitment to inclusive and intentional recruiting practices is needed to increase the representation of underrepresented groups, thus increasing the generalizability of future research.

Keywords: Clinical trial; Demographics; Obesity; Systematic review.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA 2020 flow diagram for new systematic reviews which include searches of databases and registers only. Adapted from Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71. For more information, visit:
Fig. 2
Fig. 2
Breakdown of reported biological sex demographics for each cited study and the corresponding participant cohort size
See this image and copyright information in PMC

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