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Activity Number: 483 - Multiplicity
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329138
Title: Multiplicity for a Group Sequential Trial with Biomarker Subpopulations
Author(s): Jing Zhao*
Companies: Merck
Keywords: Biomarker subpopulation; Group Sequential Design; Multiplicity Adjustment

The conventional design with only one primary study population (an overall population) has recently been challenged), particularly when the disease (e.g. cancer) is heterogeneous due to observable clinical characteristics and/or unobservable underlying biologic/genomic characteristics. In recent oncology clinical trials, biomarker subpopulations (biomarker +/-) have become increasingly important for drug development in tailored therapies to fulfill regulatory commitments. It is also desirable to optimize the study design to have a more enhanced claim in which multiple objectives can be met. In this work, we propose to extend the classical group sequential design set-up to the above setting and develop the methods and calculation with less conservative bounds and, therefore, a smaller required sample size or greater power.

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

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