Strategies to support drug clinical research in older population in the United States and European Union
ZHANG Yi-nan
Li Xin-chen
WU Ting-xi
ZHAO Zhi-gang
Abstract：China has entered an aging society,with an increasingly large elderly population. The pharmaco-kinetics and pharmacodynamics in older population may differ from those in younger adults. It is a critical foundation for rational drug use in the elderly to obtain evidence based on the older population in drug clinical research. Some developed countries have entered the aging phase earlier,thus have long been attentive to the insufficiencies in drug clinical research for geriatrics. Upon scrutinizing the websites of drug regulatory authorities in the United States and Europe,it appears that these regions have developed a series of guidelines and reports providing recommendations for drug clinical research in older population. They required that patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug. Currently,China lacks specific guidance on clinical research of older population. We could learn from other countries' experience,which involves encouraging pre-marketing clinical trials to include the older population through regulations and guidelines,as well as standardize and strengthen post-marketing studies,so as to better evaluate the drug benefit-risk and promote rational drug use in the geriatric population.
Keywords：older populationdrug clinical researchsupport strategiesageing population
Publication Date：2025-01-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1-5 )