4.6 Article

Recruitment and retention of participant and study partner dyads in two multinational Alzheimer's disease registration trials

期刊

ALZHEIMERS RESEARCH & THERAPY
卷 13, 期 1, 页码 -

出版社

BMC
DOI: 10.1186/s13195-020-00762-8

关键词

Alzheimer's disease; Clinical trials; Recruitment; Retention; Study partner

资金

  1. NIH/NIA [1RF1AG059407]
  2. National Science Foundation Graduate Research Fellowship [DGE-183928]
  3. NIA [AG066519]
  4. NCATS [UL1 TR001414]

向作者/读者索取更多资源

Early study exit in Alzheimer's disease clinical trials can reduce statistical power and increase bias risk. The type of study partner may influence the completion rate of the trial.
BackgroundEarly study exit is detrimental to statistical power and increases the risk for bias in Alzheimer's disease clinical trials. Previous analyses in early phase academic trials demonstrated associations between rates of trial incompletion and participants' study partner type, with participants enrolling with non-spouse study partners being at greater risk.MethodsWe conducted secondary analyses of two multinational phase III trials of semagacestat, an oral gamma secretase inhibitor, for mild-to-moderate AD dementia.Cox's proportional hazards regression model was used to estimate the relationship between study partner type and the risk of early exit from the trial after adjustment for a priori identified potential confounding factors. Additionally, we used a random forest model to identify top predictors of dropout.ResultsAmong participants with spousal, adult child, and other study partners, respectively, 35%, 38%, and 36% dropped out or died prior to protocol-defined study completion, respectively. In unadjusted models, the risk of trial incompletion differed by study partner type (unadjusted p value=0.027 for test of differences by partner type), but in models adjusting for potential confounding factors, the differences were not statistically significant (p value=0.928). In exploratory modeling, participant age was identified as the primary characteristic to explain the relationship between study partner type and the risk of failing to complete the trial. Participant age was also the strongest predictor of trial incompletion in the random forest model.ConclusionsAfter adjustment for age, no differences in the risk of incompletion were observed when comparing participants with different study partner types in these trials. Differences between our findings and the findings of previous studies may be explained by differences in trial phase, size, geographic regions, or the composition of academic and non-academic sites.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.6
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据