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Biometrika 1994 81(2):279-286; doi:10.1093/biomet/81.2.279
© 1994 by Biometrika Trust
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Interim analyses based on median survival times

K. M. KEANEY1 and L. J. WEI2

1Division of Clinical Epidemiology, Brigham and Women's Hospital 75 Francis Street, Boston, Massachusetts 02115, U. S.A.
2Department of Biostatistics, Harvard School of Public Health 677 Huntington Street, Boston, Massachusetts 02115, U. S.A.

For a typical two-arm survival study, analyses are usually performed periodically to evaluate, for example, the treatment difference. In this paper, we propose to use differences or ratios of estimated median survival times repeatedly during a study to evaluate the relative merit of two treatment groups. This new procedure provides quantitative assessments of the treatment difference and is completely model-free. Our method is illustrated with a recent aids clinical study which evaluates the efficacy of a reduced dose of AZT.

Key Words: Kaplan-Meier estimate • Repeated confidence intervals • Resampling method


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