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Biometrika 1988 75(2):311-318; doi:10.1093/biomet/75.2.311
© 1988 by Biometrika Trust
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Sequential testing in clinical trials with repeated measurements

D. N. GEARY

Department of Biomathematics, University of Oxford Oxford OX1 3UB, U.K.

In some clinical trials, the number of subjects on each treatment is fixed and at successive equally-spaced time points each subject yields a measurement which reflects response to treatment. A model is presented for such repeated measurements data. A sequential procedure is proposed for testing the null hypothesis of no difference in mean effect between two treatments. In this procedure, the maximum number of measurements per subject and absorption probabilities for intermediate significance tests are preassigned to yield a required approximate overall significance level. The jth significance test follows thejth measurement on each subject, and the test depends on values of model parameters estimated from all the data available so far. Simulations show that the proposed procedure yields overall significance levels close to 5% when required, for data from a variety of models.

Key Words: Autoregression • Clinical trial • Group sequential testing • Multivariate normal integral • Repeated measurements


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B. Spiessens, E. Lesaffre, G. Verbeke, K. Kim, and D. L DeMets
An overview of group sequential methods in longitudinal clinical trials
Statistical Methods in Medical Research, October 1, 2000; 9(5): 497 - 515.
[Abstract] [PDF]


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