Crossover design and its application in late-phase diabetes studies.

Abstract:

: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.

journal_name

J Diabetes

journal_title

Journal of diabetes

authors

Wang T,Malone J,Fu H,Heilmann C,Qu Y,Huster WJ

doi

10.1111/1753-0407.12412

subject

Has Abstract

pub_date

2016-09-01 00:00:00

pages

610-8

issue

5

eissn

1753-0393

issn

1753-0407

journal_volume

8

pub_type

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