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Activity Number: 39
Type: Contributed
Date/Time: Sunday, July 31, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #319657
Title: Crossover Design and Its Application in Late-Phase Diabetes Studies
Author(s): Tao Wang* and James Malone and Haoda Fu and Cory Heilmann and Yongming Qu and William Huster
Companies: and Eli Lilly and Company and and Eli Lilly and Company and Eli Lilly and Company and Eli Lilly and Company
Keywords: crossover design ; carryover effect ; washout period ; diabetes ; insulin ; late phase clinical trial

Crossover design has been widely applied in late-phase clinical studies, as well as in PK/PD studies, bioequivalence studies, and medical device studies; however, its interpretability and applicability continue to be debated. In this paper, 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 wash-out period may not be needed. A simulation study and data mining results on twelve crossover late-phase insulin clinical trials are also presented to examine the discussion points and proposals.

Authors who are presenting talks have a * after their name.

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