Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019.

ABSTRACT:

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), nonval

SUBMITTER: Lau SWJ 

PROVIDER: S-EPMC9568796 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature