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Group sequential methods in the design and analysis of clinical trials

Group sequential methods in the design and analysis of clinical trials Abstract SUMMARY In clinical trials with sequential patient entry, fixed sample size designs are unjustified on ethical grounds and sequential designs are often impracticable. One solution is a group sequential design dividing patient entry into a number of equal-sized groups so that the decision to stop the trial or continue is based on repeated significance tests of the accumulated data after each group is evaluated. Exact results are obtained for a trial with two treatments and a normal response with known variance. The design problem of determining the required size and number of groups is also considered. Simulation shows that these normal results may be adapted to other types of response data. An example shows that group sequential designs can sometimes be statistically superior to standard sequential designs. This content is only available as a PDF. © 1977 Biometrika Trust http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biometrika Oxford University Press

Group sequential methods in the design and analysis of clinical trials

POCOCK, STUART, J.
Biometrika , Volume 64 (2) – Aug 1, 1977
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References (4)

Publisher
Oxford University Press
Copyright
© 1977 Biometrika Trust
ISSN
0006-3444
eISSN
1464-3510
DOI
10.1093/biomet/64.2.191
Publisher site
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Abstract

Abstract SUMMARY In clinical trials with sequential patient entry, fixed sample size designs are unjustified on ethical grounds and sequential designs are often impracticable. One solution is a group sequential design dividing patient entry into a number of equal-sized groups so that the decision to stop the trial or continue is based on repeated significance tests of the accumulated data after each group is evaluated. Exact results are obtained for a trial with two treatments and a normal response with known variance. The design problem of determining the required size and number of groups is also considered. Simulation shows that these normal results may be adapted to other types of response data. An example shows that group sequential designs can sometimes be statistically superior to standard sequential designs. This content is only available as a PDF. © 1977 Biometrika Trust

Journal

Biometrika – Oxford University Press

Published: Aug 1, 1977

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