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Cancer Biostatistics Center /Software Tools /Two-Stage Designs

Bayesian Approaches for Two-Stage Phase II Clinical Trial Designs

Adjustable Single Threshold Design (Ming Li & Yu Shyr, 2004)

The STD (single threshold design) has been proposed by Tan and Machin (2002). Based on their design framework, we propose one modification to reduce the sample size for stage II given the very promising outcome observed from stage I. To keep it consistent to STD and as user friendly as possible, our design is a slight extension of STD yet keep its original structure to the greatest extent.

Adjustable Single Threshold Designs

In a Bayesian framework, STD two-stage design incorporates prior knowledge on the response rate with no explicit specification of utility function. The sample size for stage I and overall phase II are determined by two probability constrains.