NIA-Funded Alzheimer Centers Are More Efficient than Commercial Clinical Recruitment Sites for Conducting Secondary Prevention Trials of Dementia
NIA-Funded Alzheimer Centers Are More Efficient than Commercial Clinical Recruitment Sites for Conducting Secondary Prevention Trials of Dementia
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DOI：
10.1097/wad.0b013e3181c9983f
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发表时间：
2010-04-01
影响因子：
2.1
通讯作者：
Petersen, Ronald C.
中科院分区：
文献类型：
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作者：
Edland, Steven D.;Emond, Jennifer A.;Petersen, Ronald C.
研究参与者退出会降低统计功效并可能导致结果出现偏差，从而损害临床试验。我们使用来自一项延缓轻度认知障碍进展为阿尔茨海默病（AD）的治疗试验的数据[NEJM 2005; 352（23）：79至88]来确定研究参与者脱落的预测因素，并为未来试验的设计和实施提供信息。研究中止时间通过比例风险回归建模，在痴呆事件或试验完成时删失。在769名参与者中，230名（30%）提前停药。非白人受试者的辍学风险较高[风险比（HR）2.1，P = 0.0007]，受试者的教育程度低于大学（HR = 1.6，P = 0.02），参与者的汉密尔顿抑郁评分为6或更高（HR = 1.3，P = 0.04），未婚男性（相对于已婚男性，HR = 2.1，P = 0.003）和商业临床研究中心招募的受试者（HR = 2.2，相对于由NIA资助的AD研究中心招募的参与者，P < 0.0001）。与使用NIA资助的AD研究中心的试验相比，使用商业研究中心的试验（具有本试验中经历的停药率和痴呆事件发生率）将需要80%以上的参与者。有针对性的保留努力和学术网站的利用可以大大提高未来认知障碍老年人临床试验的统计能力和有效性。
Study participant dropout compromises clinical trials by reducing statistical power and potentially biasing findings. We use data from a trial of treatments to delay the progression of mild cognitive impairment to Alzheimer disease (AD) [NEJM 2005; 352 (23):79 to 88] to determine predictors of study participant dropout and inform the design and implementation of future trials. Time to study discontinuation was modeled by proportional hazards regression with censoring at incident dementia or trial completion. Of 769 participants, 230 (30%) discontinued prematurely. Risk of dropout was higher among nonwhites [hazard ratio (HR) 2.1, P = 0.0007], participants with less than college education (HR = 1.6, P = 0.02), participants with a Hamilton Depression score of 6 or more (HR = 1.3, P = 0.04), unmarried males (HR = 2.1 relative to married males, P = 0.003) and participants recruited by commercial clinical sites (HR = 2.2 relative to participants recruited by NIA-funded AD research centers, P < 0.0001). A trial using commercial sites with the discontinuation rates and incident dementia event rates experienced in this trial would require 80% more participants than a comparably powered trial using NIA-funded AD research center sites. Targeted retention efforts and utilization of academic sites could substantively improve the statistical power and validity of future clinical trials of cognitively impaired elderly.