新药研发与临床研究中对于老年人群的若干考虑

Considerations for Older Adults in New Drug Development and Clinical Research

随着人口老龄化加剧,老年人群的用药需求日益迫切。老年人由于病理生理变化、多病共存和多重用药等情况,对药物的反应可能与年轻人存在显著差异,需要有针对性地进行药物研发和剂量调整。然而,老年人,尤其是高龄(80岁以上)老人,往往被排除在临床研究之外。这导致缺乏足够的研究数据以支持该年龄组安全、合理用药。新药研发是一项关乎老年人福祉的重大课题,需要政府、医药企业、科研机构等多方携手合作,深入研究老年人群的用药特点,建立科学、合理的老年用药评估体系,通过政策导向和科学引导,来保障老年人群用药的安全性和有效性。文章基于我国老年人群中新药研发的现状及国内外监管科学的进展情况,探讨了针对老年人群的新药开发和临床研究的关键考虑因素。

As the population ages,the need for medications tailored to older adults becomes increasingly critical.Due to pathophysiological changes,comorbidities,and polypharmacy,older adults may respond differently to drugs than younger individuals.This necessitates targeted drug development and adjusted dosages.However,older adults,particularly those over 80 years of age,are often underrepresented in clinical trials.This lack of research data hinders the safe and effective use of medications in this age group.New drug development and clinical research hold immense potential for improving the well-being of older adults.To achieve this,strong collaboration between governments,pharmaceutical companies,and research institutions is essential.In-depth studies on how medications interact with the aging body are crucial.Furthermore,establishing a robust scientific evaluation system,informed by both policy and scientific advancements,is paramount to ensure the safety and efficacy of medications for older adults.This article explores key considerations for new drug development and clinical research specific to this growing demographic,taking into account both domestic and international regulatory developments.