Predictive Probability Early Termination Plans For Phase II Clinical Trials

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Abstract
A phase II clinical trial is designed to gather data to help decide whether an experimental treatment has sufficient effectiveness to justify further study. In a one-arm trial with dichotomous outcome, a simple null hypothesis on the Bernoulli parameter was tested against a 1-sided alternative in a sample of N patients. A rule to terminate the trial early should exist when the treatment is ineffective. Predictive probabilities based on the binomial distribution and beta and uniform prior distributions for the binomial parameter are useful as the basis of group sequential designs. Size, power and average sample size for these designs are discussed. A process for the specification of an early termination plan, advice on the quantification of prior beliefs and illustrative examples are included.

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