JSM 2004 - Toronto

Abstract #300024

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Activity Number: 142
Type: Invited
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300024
Title: Hybrid Adaptive Designs for Clinical Trials
Author(s): Peter F. Thall*+
Companies: University of Texas M. D. Anderson Cancer Center
Address: Biostatistics & Applied Mathematics Dept., Box 447, Houston, TX, 77030,
Keywords: clinical trials ; Bayesian design ; adaptive decision rules ; dose-finding ; adaptive randomization
Abstract:

Clinical trials can be quite complex, often involving multiple stages of therapy, multivariate outcomes, and multiple goals. Consequently, the conventional "phase I, phase II, phase III" paradigm often is inadequate and a hybrid design, tailored to the particular trial at hand, must be constructed. I will describe two such hybrid designs, both Bayesian and both utilizing outcome-adaptive decision rules. The first is a method for dose-finding that combines efficacy and toxicity in terms of a function quantifying the trade-off between the probabilities of these outcomes. This will be illustrated by a trial of an agent for treatment of graft-versus-host disease in stem cell transplantation. The second is a design for a multicenter trial to compare gemcitabine +/- docetaxel for unresectable soft tissue sarcoma. The trial design uses Bayesian, covariate-adjusted adaptive randomization probabilities based on a trinary outcome observed in each of up to four courses of therapy. A computer simulation study of each design will be described.

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Revised March 2004