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.
- Two-Stage Designs for Phase II Clinical Trials --- Uncorrelated Data
- Two-Stage Designs for Phase II Clinical Trials --- Correlated Data
- To Verify Type I/II Error Rates and Power of Two-Stage Phase II Designs