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Activity Number: 85
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #315325
Title: Sequential Basket Design with Subgroups Defined by Predictive Biomarker and Cancer
Author(s): Shuai Yuan*
Companies: Merck
Keywords: Predictive Biomarker ; Basket Trial ; Pruning ; Heterogeneity of Populations ; FWER ; Multiple Testing
Abstract:

Efficient pruning is critical in basket trial designs of target therapy where different tumor indications are studied in the same trial, as it ensures the internal consistency of the selected tumor indications in subgroups defined by the predictive biomarker and tumor indications. In this manuscript, we consider pruning both inactive and extremely active indications and propose a group sequential enrichment design with testing procedures to both control the FWER and maintain the power for basket trials with such pruning strategy. We compare the proposed design with a relevant design which prunes only unresponsive subgroups. The total misclassification rates and misclassification rates among truly unresponsive indications are smaller for the proposed design, while the average power is similar.


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