This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 454
Type: Topic Contributed
Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #307304
Title: Efficient Early Phase Designs in Oncology Based on Evidence Synthesis
Author(s): Jyotirmoy Dey*+ and Wentao Feng
Companies: Novartis Pharmaceuticals Corporation and Novartis Pharmaceuticals Corporation
Address: 180 Park Avenue, Florham Park, NJ, 07932,
Keywords: Evidence synthesis ; Bayesian ; historical controls ; Early clinical trial ; Oncology

In this talk we discuss examples of early phase Oncology designs that seek to gain efficiency through Bayesian evidence synthesis. Clinical study planning frequently rely, albeit informally, on relevant information from experiments in similar clinical context, e.g. same stage and severity of disease, drugs of the same class, etc. Through simple applications in early clinical trials using a Bayesian framework we allow formal incorporation of such information to provide useful benchmarking of efficacy or safety signals. Efficiency is gained mainly through improvement in decision operating characteristics or precision of estimates. Examples range from implementation in both phase I and II, and from utilizing information from historical controls to synthesis across multiple concurrent study arms.

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