Obesity Underrepresentation in Clinical Trials Leads to Concerns Over Drug Efficacy and Safety

October 16, 2023

Obesity is often not represented adequately in drug development trials, causing uncertainties about drug efficacy and risks in patients with obesity. Research presented at the ObesityWeek conference revealed that 64% of 201 drug approval studies from 2022 did not include weight or BMI-based criteria, thereby excluding obese individuals. In the cases where such measures were used, 75% of the trials excluded patients with obesity. Lack of representation and additional stigma associated with obesity result in insufficient drug effectiveness and safety data, potentially leading to adverse effects. The FDA has acknowledged these gaps but has yet to implement regulatory requirements addressing weight as a specific issue. Experts propose mandating obesity inclusion in trials, including drug impact information in package inserts for obese patients, and implementing a reporting system for tracking adverse events in individuals with obesity.

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[Source: STAT, October 16th, 2023]

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