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Question Are older adults adequately represented in clinical trials for new drug evaluation? Findings In this cross-sectional study, adults in the oldest age groups above age 75 years or in some therapeutic areas above age 80 years in clinical trials were not enrolled in proportion to the prevalence of selected treatment indications in the US from 2010 through 2019. However, participants between ages 60 and 75 years were reasonably proportional with the prevalence of selected treatment indications. Meaning These results suggest that a lack of adequate representation of older adults in clinical trials for new drug evaluation can present challenges for optimal use and prescribing. This cross-sectional study examines the proportions of enrollment for older adults in clinical trials for new drug and biologics license applications with the US Food and Drug Administration relative to the US population. Importance Older age may be accompanied by changes in the pharmacokinetics or pharmacodynamics or both of medications that can result in altered safety and efficacy profiles. Objective To assess representation of older adults in clinical trials of new drug applications (NDAs) and biologics license applications (BLAs). Design, Setting, and Participants This cross-sectional study analyzed US Food and Drug Administration (FDA) data for NDAs and BLAs approved from 2010 through 2019. Age distribution of clinical trial participants was compared with age distribution of the US population with the disease or disorder (prevalent population). Data were from adults enrolled in registration trials for depression, heart failure, insomnia, non–small cell lung cancer (NSCLC), nonvalvular atrial fibrillation (NVAF) stroke prevention, osteoporosis, and type 2 diabetes or adults sampled from US prevalent population in community-dwelling health data. Data were analyzed from November 2020 to February 2021. Exposures Trial enrollment. Main Outcomes and Measures Representativeness of trial populations was assessed by the participation to prevalence ratio (PPR) defined as the percentage of patients by age group among clinical trial participants to the percentage of patients by age group among US prevalent population. Results Data from 166 clinical trials (229 558 participants) for 44 NDAs and BLAs were analyzed. The most consistent finding was the limited enrollment of the oldest age groups, namely those 75 years and above for type 2 diabetes and NSCLC, and 80 years and above for NVAF stroke prevention, insomnia, heart failure, and osteoporosis. Adults aged 60 to 74 years were enrolled in equal or greater proportion than the US prevalent population. Conclusions and Relevance In this cross-sectional study, underrepresentation of the oldest adults existed during evaluation of new drugs and biologics, yet the older adults may represent significant proportions of the treatment population. Closing the representation gap between clinical trial enrollment and potential treatment populations is essential for safe and effective use of new drugs and biologics.
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