Open AccessCrossover design and its application in late‐phase diabetes studies
Author(s) -
Wang Tao,
Malone James,
Fu Haoda,
Heilmann Cory,
Qu Yongming,
Huster William J.
Publication year - 2016
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12412
Subject(s) - medicine , diabetes mellitus , crossover study , crossover , phase (matter) , research design , endocrinology , statistics , alternative medicine , artificial intelligence , mathematics , computer science , chemistry , organic chemistry , pathology , placebo
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.