Quantifying the Gap: How Clinical Trials Misrepresent Age and Sex in Target Populations
A systematic analysis of 458 new drugs approved by the FDA between 2011 and 2022 reveals a persistent mismatch between the demographics of clinical trial participants and the real-world populations who will use the medications. On average, trial participants were nearly five years younger than the target patient population, and the proportion of women was 4.3 percentage points lower. This disparity was most pronounced for diseases affecting older adults, where trials enrolled significantly younger and more male cohorts than the prevalence data would suggest.
Why it might matter to you:
This evidence of systematic underrepresentation in trials has direct implications for the safety and efficacy profiles of medications you prescribe, particularly for older patients and women with diabetes. It underscores the need for critical appraisal of trial data when managing complex diabetic complications, where polypharmacy and age-related pharmacokinetics are common. The findings advocate for a more nuanced, population-informed approach to clinical guidelines and therapeutic decision-making in chronic disease management.
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