JSM 2005 - Toronto

Abstract #302939

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 320
Type: Contributed
Date/Time: Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #302939
Title: Assessing Carryover Effects from Multiple Crossover Trials
Author(s): Mary Putt*+
Companies: University of Pennsylvania
Address: , Philadelphia, PA, 19104, United States
Keywords: crossover trials ; carryover effects ; bioequivalence ; hypothesis testing
Abstract:

The potential for carryover effects is an important consideration in the design of a crossover study and can cause an investigator to abandon the design altogether. Carryover effects are differences in the extent of carryover and the lingering effect of a treatment into the subsequent period between two treatments under consideration. The test for carryover effects in individual studies has low power. Evaluating the distribution of p-values in a collection of studies might provide a more powerful way of testing for carryover effects. However, our results suggest the power to detect clinically relevant carryover effects is small and the number of studies needed to differentiate this effect from the Type I error rate prohibitive. Additionally, for bioequivalence studies, even moderate carryover effects (10% of the treatment effect) can inflate the Type I error rate, and the power to detect these levels of carryover is very low. Unequivocal conclusions about the absence of carryover effects based on collections of hypothesis tests appear unlikely.

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