Group sequential designs for developing and testing biomarker-guided personalized therapies in comparative effectiveness research
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Updated: May 8, 2026

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
Tze Leung Lai1, Olivia Yueh-Wen Liao, Dong Woo Kim
1Department of Statistics, Stanford University, Stanford, CA, USA.
Abstract:
Biomarker-guided personalized therapies offer great promise to improve drug development and improve patient care, but also pose difficult challenges in designing clinical trials for the development and validation of these therapies. We first give a review of the existing approaches, briefly for clinical trials in new drug development and in more detail for comparative effectiveness trials involving approved treatments. We then introduce new group sequential designs to develop and test personalized treatment strategies involving approved treatments.
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