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Activity Number: 664
Type: Invited
Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #314173
Title: New Developments in Biomarker-Based Oncology Trial Design
Author(s): Daniel Sargent*
Companies: Mayo Clinic
Keywords: Biomarkers ; clinical trials ; oncology ; adaptive design
Abstract:

Increasing scientific knowledge is creating both substantial opportunities and challenges in oncology drug development. As diseases are sub-stratified into often biomarker-based groups, usual paradigms for phase II and III disease may no longer apply. Enrichment designs are appropriate when preliminary evidence suggest that patients with/without that marker profile do not benefit from treatments in question; however this may leave questions unanswered (e.g. Herceptin and breast cancer). An unselected design is optimal where preliminary evidence regarding treatment benefit and assay reproducibility is uncertain. Adaptive analysis designs allow for pre-specified marker defined subgroup analyses of data from a RCT. We discuss features of these various novel design strategies in the context of real trials.

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

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