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Cancer Biostatistics Center /Software Tools /Two-Stage Designs

Frequentist Approaches for Two-Stage Phase II Clinical Trial Designs

Balanced Design (Fei Ye and Yu Shyr, Clin Trials. 2007; 4(5):514-24)

The balanced design provides an additional choice for two-stage phase II trials when the investigators would like to monitor the trial near a study's halfway point. Meanwhile, its total sample sizes are comparable with Simon's designs.

Optimal and Minimax Designs (Richard Simon, 1988)

Optimal Design: the expected sample size is minimized if the investigational treatment has low activity subject to the constraints upon the size of type I and type II errors.

Minimax Design: minimizes the maximum sample size subject to the constraints upon the size of type I and type II errors.