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Activity Number: 246
Type: Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305557
Title: An Investigation of Effect of Baseline Definition in Parallel Nested Crossover Studies
Author(s): Hui Zhi*+ and Gary Koch
Companies: GlaxoSmithKline and The University of North Carolina at Chapel Hill
Address: Five Moore Drive, RTP, NC, 27709, United States
Keywords: Baseline ; Nested Crossover ; QTc study ; assay sensitivity

In early phase clinical trials, parallel nested crossover studies are sometimes used for long half-life compounds. In such studies, more than one definition of baseline is possible for the nested crossover part. We are interested in understanding the implications of two particular definitions. We consider a real Phase I, randomized, parallel group, nested crossover study to demonstrate no test drug effect as compared with placebo on cardiac repolarization QTc after 6 weeks of treatment. In the study, Moxifloxacin was given as a positive control in the nested crossover design in order to validate the sensitivity of the study to detect a change in the QTc exceeding 5 ms. The main endpoint of the assay analysis is the change from baseline. We investigate two proposals with different baseline definitions. The first proposal uses the baseline for the corresponding period to calculate the change from baseline. As an alternative, the second proposal uses "no treatment" control data (i.e. ECG data when no treatment is administered) as the baseline in the calculation. We use both methods for the univariate and multivariate modeling to evaluate the relationships between the two proposals.

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