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Biometrika 1990 77(2):359-364; doi:10.1093/biomet/77.2.359
© 1990 by Biometrika Trust
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Interim analyses with repeated measurements in a sequential clinical trial

L. J. WEI, JOHN Q. SU and JOHN M. LACHIN

Department of Statistics, University of Wisconsin Madison, Wisconsin 53706, U.S.A.
Biostatistics Center, George Washington University Rockville, Maryland 20852, U.S.A.

In comparing two treatments, suppose that patients are available for the study sequentially. Repeated measurements of the same characteristic are collected serially over time for each study patient. Sequential procedures are proposed to monitor the trial for early evidence of treatment difference or harmful side effects based on such repeated measurements. All the methods are illustrated with a real-life example.

Key Words: Data-dependent boundary • Generalized linear model • Group sequential testing • Repeated confidence intervals


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