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Activity Number: 263
Type: Contributed
Date/Time: Monday, August 1, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #320681
Title: Bayesian Noncomparative Designs to Account for Uncertainty in Historical Response Rates
Author(s): Francesca Matano* and Valeria Sambucini
Companies: Carnegie Mellon University and University of Rome "La Sapienza"
Keywords: Bayesian power functions ; phase II clinical trials ; single-arm two-stage designs ; analysis and design prior
Abstract:

Non-comparative two-stage designs based on a binary response variable are typically used in phase II clinical trials. In these designs the response rate of the experimental treatment is compared with a fixed target value that should represent the true response rate for the standard agent. Usually this target value is estimated by exploiting historical data, but no variability is taken into account. In this work we address one of the major concerns about the use of historical controls - i.e. the potential bias in the comparison - by proposing Bayesian single-arm two-stage designs, that allow to incorporate uncertainty in the response rate of the standard treatment. The two-stage sample sizes are selected by ensuring a large posterior probability of declaring the new treatment more effective than the standard one, under the assumption that the new treatment is indeed better in efficacy.


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

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