Addressing the challenges to successful recruitment and retention in Alzheimer's disease clinical trials.
Addressing the challenges to successful recruitment and retention in Alzheimer's disease clinical trials.
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DOI：
10.1186/alzrt58
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发表时间：
2010-12-21
期刊：
影响因子：
--
通讯作者：
Karlawish J
中科院分区：
文献类型：
--
作者：
Grill JD;Karlawish J
阿尔茨海默病药物开发的关键挑战之一是及时完成临床试验。不幸的是，临床试验通常会遇到登记缓慢或不足的问题。成功的临床试验招募描述了在迅速实现完全登记和确保适当的研究样本之间的平衡。调查人员在成功达成这一平衡的谈判中面临着许多挑战。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金钱，试验结果可能不能充分代表药物疗效，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的挑战，并提出了一个解决这些挑战的框架。
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.
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