Analysis of older adults inclusion in clinical trials of FDA-approved new drugs in the United States
DING Jing
XU Yang
YANG Yue
TIAN Li-juan
Abstract：Objective:To address the underrepresentation of older adults in clinical trials of new drugs,the U.S.FDA has implemented various measures to encourage their participation.This study systematically assesses the enrollment of older adults in clinical trials for FDA-approved new drugs between 2015 and 2023,with the aim of informing strategies for geriatric drug development in China.Methods:Demographic data for approved drug indications were extracted from the FDA drug trials snapshots(DTS).Therapeutic areas were categorized according to the WHO anatomical therapeutic chemical(ATC)classification.The proportions of participants aged<65 years,≥65 years,and≥75 years were analyzed.Compliance with the ICH E7 guideline-especifically the inclusion of at least 100 older adults in non-elderly-specific and rare disease indications-was also evaluated.Results:Among 381 non-elderly-specific indications,85.3%included participants aged≥65 years.However,only 43.0%included≥100 older adults,and only 16.8%disclosed data for the≥75-year-old subgroup.In terms of therapeutic area,the sensory system showed the highest level of inclusion(100%included older adults;90.9%included≥100),while the musculoskeletal system had the lowest(only 28.6%included participants aged≥65).The inclusion rate for older adults in rare disease indications was significantly lower than that in non-rare diseases(79.6%vs 90.8%,P=0.0074),with only 23.1%meeting the ICH E7"≥100 older adults"threshold(vs.60.0%in non-rare diseases,P<0.0001).Conclusion:Through transparency initiatives and updated regulatory policies,the FDA has made tangible progress in enhancing the representation of older adults in clinical trials.However,gaps remain in the data reporting for very old subgroups(≥75 years).These findings provide key insights for advancing the development of age-inclusive drug research in China.
Keywords：FDAdrug trials snapshotsclinical trialsgeriatric useICH E7
Publication Date：2026-03-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 449-454 )