JSM 2004 - Toronto

Abstract #300660

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Activity Number: 148
Type: Topic Contributed
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #300660
Title: An Exact P Value from Multistage Phase II Clinical Trials
Author(s): Sin-Ho Jung*+ and Kouros Owzar and Stephen George
Companies: Duke University and Duke University and Duke University
Address: DUMC Box 3627, Durham, NC, 27710,
Keywords: stochastic ordering ; uniformly minimum variance unbiased estimator ; maximum likelihood estimator
Abstract:

When we perform a statistical testing, we calculate a p value to see how significant the statistical evidence is against the null hypothesis from the data. Due to ethical and practical issues, clinical trials are conducted in multiple stages, but the reported p values often fail to reflect the design aspect of the trials. We propose an exact p value for analysis of multistage phase II clinical trials which have a binary variable, such as response, as the primary endpoint. The sample space consists of the paired observations of the stopping stage and the number of responses, which are jointly complete and sufficient statistic for the true binomial proportion. Our p value calculation is based on the ordering of sample space defined by uniformly minimum variance unbiased estimator. We will compare our p value with the one based on ordering defined by maximum likelihood estimator and the one ignoring multistage design aspect of phase II trials.

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