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解决阿尔茨海默病临床试验中成功招募和保留的挑战。

Addressing the challenges to successful recruitment and retention in Alzheimer's disease clinical trials.

机构信息

Mary S Easton Center for Alzheimer's Disease Research, Department of Neurology, University of California, Los Angeles, 10911 Weyburn Avenue, Suite 200, Los Angeles, CA 90095, USA.

出版信息

Alzheimers Res Ther. 2010 Dec 21;2(6):34. doi: 10.1186/alzrt58.

Abstract

Among the key challenges in Alzheimer's disease drug development is the timely completion of clinical trials. Unfortunately, clinical trials often suffer from slow or insufficient enrollment. Successful clinical trial recruitment describes a balance between expeditiously achieving full enrollment and ensuring an appropriate study sample. Investigators face a number of challenges to the successful negotiation of this balance. The failure to address these challenges means that drug development may take more time and money and that trial results may not adequately represent drug efficacy or may not be applicable beyond the study. We review the challenges to recruitment and retention in Alzheimer's disease clinical trials and present a framework to address them.

摘要

在阿尔茨海默病药物开发的主要挑战中,及时完成临床试验是一个挑战。不幸的是,临床试验往往因招募速度慢或招募人数不足而受阻。成功的临床试验招募描述了快速完成全部入组和确保适当研究样本之间的平衡。研究人员在成功达成这种平衡方面面临着许多挑战。未能解决这些挑战意味着药物开发可能需要更多的时间和资金,而且试验结果可能无法充分反映药物的疗效,或者可能不适用于研究之外的情况。我们回顾了阿尔茨海默病临床试验中招募和保留方面的挑战,并提出了一个解决这些挑战的框架。

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