Crossover design and its application in late-phase diabetes studies 交叉设计及其在晚期阶段糖尿病研究中的应用

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• 作者：Tao Wang ; James Malone ; Haoda Fu ; Cory Heilmann ; Yongming Qu and William J. Huster
• 刊名：Journal of Diabetes
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：8
• 期：5
• 页码：610-618
• 全文大小：488K
• ISSN：1753-0407

文摘

Crossover design has been widely used in late-phase clinical studies, as well as in pharmacokinetic and pharmacodynamic, bioequivalence, and medical device studies; however, its interpretability and applicability continue to be debated. Herein we provide discussions around a crossover design's scientific benefit, applicability, and how it can be implemented in late-phase diabetes studies by properly handling key issues: carryover effect, washout period, and baseline selection. Specifically, detailed considerations are provided about the validity and situations of having appropriate length of study duration to deal with carryover effects so that a washout period may not be needed. A simulation study and data mining results on 12 crossover late-phase insulin clinical trials are presented to examine the discussion points and proposals.