Representation of Older Adult Patients in Clinical Trials.

ABSTRACT: Older adults remain significantly underrepresented in clinical trials. This is concerning because age-associated physiological changes can alter drug pharmacokinetics and pharmacodynamics. This paper examines the status of older adult representation in clinical trials, analyzes contributing factors, and discusses initiatives to address gaps. Data were collected from studies completed between 2010 and 2025 using ClinicalTrials.gov to assess age-related inclusion/exclusion criteria. Further, two surveys of pharmaceutical companies were initially conducted to assess age ranges of randomized patients in pivotal trials, what clinical pharmacology approaches were applied to potentially support dosing in older adult patients, whether exclusion criteria disproportionally excluded older patients, r

SUBMITTER: Haertter S 

PROVIDER: S-EPMC12614078 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature