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

Doris Molina-Henry, Rema Raman
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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.

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随机对照试验(RCT)的参与者招募和保留是一门不断发展和演变的科学。鉴于必须根据独特的试验设计考虑因素做出重要而关键的选择,各学科的情况也大不相同。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所处的疾病阶段而异,目标人群可从有疾病生物标志物证据的无症状成人到终末期症状管理者。本章讨论了现有的障碍,并提出了在多中心AD试验中实现包容性和及时招募的建议。它提出了一个循证招募框架,该框架立足于文化认知和以参与者为中心的研究层面和研究机构层面的工作。
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来源期刊
Current topics in behavioral neurosciences
Current topics in behavioral neurosciences Neuroscience-Behavioral Neuroscience
CiteScore
4.80
自引率
0.00%
发文量
103
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