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Biometrika 1988 75(2):303-310; doi:10.1093/biomet/75.2.303
© 1988 by Biometrika Trust
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Two-stage selection and testing designs for comparative clinical trials

PETER F. THALL, RICHARD SIMON and SUSAN S. ELLENBERG

Department of Statistics/Computer & Information Systems, George Washington University Washington, D.C. 20892, U.S.A.
National Cancer Institute Bethesda, Maryland 20892, U.S.A.

A two-stage design which selects the best of several experimental treatments and compares it to a standard control is proposed. The design allows early termination with acceptance of the global null hypothesis. Optimal sample size and cut-off parameters are obtained by minimizing expected total sample size for fixed significance level and power.

Key Words: Clinical trial • Expected sample size • Optimal design • Selection • Two-stage design


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