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A Bayesian Decision Approach For Sample Size Determination In Phase Ii Trials, Denis H. Y. Leung, You-Gan Wang

Research Collection School Of Economics

Stallard (1998, Biometrics54, 279–294) recently used Bayesian decision theory for sample-size determination in phase II trials. His design maximizes the expected financial gains in the development of a new treatment. However, it results in a very high probability (0.65) of recommending an ineffective treatment for phase III testing. On the other hand, the expected gain using his design is more than 10 times that of a design that tightly controls the false positive error (Thall and Simon, 1994, Biometrics50, 337–349). Stallard's design maximizes the expected gain per phase II trial, but it does not maximize the rate of gain or …