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

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.

Liraglutide 3.0 mg in the treatment of adults with obesity and prediabetes using real‐world UK data: A clinical evaluation of a multi‐ethnic population

“…Secondly, we included a diverse population in terms of socioeconomic status and ethnicity, including a significant proportion of Black African and Caribbean ethnicity individuals. This is important as clinical trial data includes primarily those of white ethnicity 48 . Third, our programme was entirely state‐funded via the NHS, which may have increased the uptake of liraglutide compared to other healthcare systems.…”

“…This is important as clinical trial data includes primarily those of white ethnicity. 48 Third, our programme was entirely state-funded via the NHS, which may have increased the uptake of liraglutide compared to other healthcare systems. In fact, the median multiple deprivation index was 3, indicating our population was from relatively high levels of socioeconomic deprivation.…”

Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities

“…The authors concluded that Black Americans and Hispanics who have a high prevalence of obesity were under‐represented, even in the trials that focused on obesity. Further, they state that the clinical study sites were often located in regions of the country where the prevalence of obesity is lower, and that the location of study sites in urban areas can add to this disparity, as populations in rural areas may benefit more from participation 25 …”

“…Further, they state that the clinical study sites were often located in regions of the country where the prevalence of obesity is lower, and that the location of study sites in urban areas can add to this disparity, as populations in rural areas may benefit more from participation. 25…”

Comparative Effectiveness of Semaglutide and Tirzepatide for Weight Loss in Adults with Overweight and Obesity in the US: A Real-World Evidence Study

“…While tirzepatide produces greater weight loss than semaglutide in patients with T2D [11], head-to-head trials evaluating these therapies in patients with overweight or obesity are not yet available. Further, it remains unclear whether the magnitude of weight loss observed in real-world settings mirrors that observed in RCTs, given well-described differences between these populations [12][13][14]. Finally, because these medications are costly and insurance coverage is limited for patients without T2D, real-world adherence may be reduced, attenuating the treatment effect in real-world settings.…”