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Biometrika 1999 86(3):517-529; doi:10.1093/biomet/86.3.517
© 1999 by Biometrika Trust
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Interim analyses using repeated confidence bands

XJ HuA1 and SW LagakosA2

Department of Biostatistics, Harvard School of Public Health, 655 Huntington Avenue, Boston, MA, 02115, USA A1 joanhu@sdac.harvard.edu A2 lagakos@biostat.harvard.edu

Clinical trials often include interim analyses that compare treatment groups with respect to the mean function of a response process. Sometimes it is unclear how the mean functions of the groups might differ, and thus one cannot confidently prespecify a simple metric upon which a stopping rule or repeated confidence interval can be based. This motivated us to extend the repeated confidence intervals approach for a finite-dimensional parameter (Jennison & Turnbull, 1989) to the use of repeated confidence bands for the mean function of a response process. Formal tests of hypotheses are easily constructed from the repeated confidence bands. We also describe how inferences for the mean function can be adaptively restricted to different subsets of its domain at different interim analyses. An example is given involving an AIDS clinical trial.

Key Words: Clinical trial; Group sequential analysis; Mean function; Nonparametric inference


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L. Zhao, X. J. Hu, and S. W. Lagakos
Statistical monitoring of clinical trials with multivariate response and/or multiple arms: a flexible approach
Biostat., April 1, 2009; 10(2): 310 - 323.
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