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实现阿尔茨海默病药理学临床试验的包容性。

Achieving Inclusion in Pharmacological Clinical Trials for Alzheimer's Disease.

作者信息

Molina-Henry Doris, Raman Rema

机构信息

Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.

出版信息

Curr Top Behav Neurosci. 2025;69:229-242. doi: 10.1007/7854_2024_522.

Abstract

Participant recruitment and retention into randomized controlled trials (RCTs) is a growing and evolving science. It varies dramatically by discipline given the important and key choices that must be made based on the unique trial design considerations. In the field of Alzheimer's Disease (AD) therapeutics, recruitment goals, approaches, and strategies vary based on the disease stage of the target population which can range from asymptomatic adults with biomarker evidence of the disease to end-stage symptom management. This chapter discusses existing barriers and provides recommendations to achieve inclusive and timely recruitment in multi-center AD trials. It proposes an evidence-based recruitment framework anchored on culturally cognizant and participant focused study level and study site level efforts.

摘要

将参与者招募并保留在随机对照试验(RCT)中是一门不断发展的科学。鉴于必须根据独特的试验设计考虑因素做出重要且关键的选择,招募情况因学科而异。在阿尔茨海默病(AD)治疗领域,招募目标、方法和策略因目标人群的疾病阶段而异,目标人群范围从有疾病生物标志物证据的无症状成年人到终末期症状管理。本章讨论了现有的障碍,并为在多中心AD试验中实现包容性和及时招募提供了建议。它提出了一个基于证据的招募框架,该框架以文化认知和以参与者为重点的研究层面及研究地点层面的努力为基础。

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