Randomized two- stage phase II clinical trial designs based on Barnard’s exact test

Document Type



In areas such as oncology, two-stage designs are often preferred as compared to one-stage designs due to the ability to stop the trial early when faced with evidence of lack of sufficient efficacy and the associated sample size savings. We present exact two-stage designs based on Barnard's exact test for differences in proportions and compare the designs to those proposed by Kepner ( 2010 ) and Jung ( 2010 ). In addition, we present tables of decision rules under a variety of assumed realities for use in trial planning. The procedure is recommended for use due to the substantial sample size savings experienced.


Clinical Trials | Medicine and Health Sciences | Oncology | Statistical Methodology | Statistics and Probability | Vital and Health Statistics


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