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Biometrika 1982 69(3):661-663; doi:10.1093/biomet/69.3.661
© 1982 by Biometrika Trust
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MISCELLANEA

Asymmetric group sequential boundaries for monitoring clinical trials

DAVID L. DEMETS and JAMES H. WARE

Mathematical and Applied Statistics Branch, National Heart, Lung and Blood Institute Bethesda, Maryland, U.S.A.
Department of Biostatistics, Harvard School of Public Health Boston, Massachusetts, U.S.A.

A group sequential method is proposed for the periodic analysis of accumulating data in clinical trials which are essentially one-sided as in treatment-placebo studies. The proposed boundaries retain the early stopping properties of the procedure described previously by DeMets & Ware (1980) when treatment appears to be ineffective or harmful but incorporate the more stringent requirements of the model proposed by O'Brien & Fleming (1979) for early rejection of the null hypothesis in favour of treatment.

Key Words: Asymmetric boundaries • Clinical trial • Early termination • Group sequential


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