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Repeated Significance Testing in Longitudinal Clinical Trials

Sandra J. Lee, Kyungmann Kim and Anastasios A. Tsiatis
Biometrika
Vol. 83, No. 4 (Dec., 1996), pp. 779-789
Published by: Oxford University Press on behalf of Biometrika Trust
Stable URL: http://www.jstor.org/stable/2337282
Page Count: 11
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Repeated Significance Testing in Longitudinal Clinical Trials
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Abstract

When longitudinal clinical trials are monitored, multiplicity from repeated significance testing as well as from repeated measures has to be accounted for properly to control the overall type I error. This often involves a multidimensional integration procedure to compute group sequential boundaries. We establish an independent increments structure of sequentially computed test statistics based on the generalised estimating equations of Liang & Zeger (1986) for longitudinal data. This simplifies the computational procedure for group sequential boundaries to one involving recursive one-dimensional integrations and allows the use of standard methodology for group sequential tests. We also apply the error spending function approach of Lan & DeMets (1983) by defining information fraction in this setting.

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