Department of Medicine, Divisions of Geriatrics and Clinical Pharmacology, University of California, San Francisco, San Francisco, California, USA.
J Am Geriatr Soc. 2024 Sep;72(9):2894-2902. doi: 10.1111/jgs.18912. Epub 2024 Apr 10.
Under-representation of subgroups of the population in clinical trials has been and continues to be a problem despite goals of academia, industry, and government. Older adults are among the groups that are under-represented in trials of medications that they are likely to receive once marketing approval has been received. Recent legislation that mandates that clinical trial participants be representative of patient population has been passed and creates hope that greater numbers of older adults will be enrolled in clinical trials and that they will be representative of "typical" geriatric patients. However, there is the need for collection of current data on disease prevalences with granularity as to age, gender, and race as well as geriatric co-morbidities to assess the representativeness of clinical trial participants relative to patient populations. Consensus on definitions and collection of data relevant to geriatric patient populations are needed to evaluate effects of comorbidities, frailty, cognitive and physical function. There will also be a need for expansion of the geriatric research workforce, facilities for research both in academic centers but also in the community and long-term care facilities, and for engagement with and involvement of communities that have been traditionally under-represented to conduct clinical trials that enroll truly representative patient populations.
尽管学术界、工业界和政府都有目标，但在临床试验中，人群的亚组代表性不足的问题一直存在，并将继续存在。在获得营销批准后，老年人是接受药物试验代表性不足的群体之一。最近通过了一项立法，要求临床试验参与者能够代表患者群体，这给更多的老年人参与临床试验并成为“典型”老年患者的代表带来了希望。然而，有必要收集有关疾病流行率的当前数据，其粒度要细到年龄、性别和种族以及老年合并症，以评估临床试验参与者相对于患者群体的代表性。需要就与老年患者群体相关的数据收集和定义达成共识，以评估合并症、虚弱、认知和身体功能的影响。还需要扩大老年研究人员队伍，为学术中心以及社区和长期护理机构的研究提供设施，并与传统上代表性不足的社区合作，开展真正具有代表性的患者群体的临床试验。
