On group sequential designs comparing two binomial proportions.

J Biopharm Stat

Statistics and Evaluation Center, American Cancer Society, Atlanta, Georgia 30303-1002, USA.

Published: January 2010

Discussed is the problem of sample size determination for one- and two-stage hypothesis tests comparing two binomial proportions using two independent random samples. A FORTRAN compiled search algorithm identifies exact group sequential designs that allow early stopping only for futility or only for efficacy or for either futility or efficacy. The resulting designs yield a substantial savings in terms of total sample size in many practical cases, are seen to satisfy a number of desirable properties, and are compared to other exact one- and two-stage designs and to designs derived based upon asymptotic normal theory methods.

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http://dx.doi.org/10.1080/10543400903280621DOI Listing

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