Group sequential methods in the design and analysis of clinical trials

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ID: 291512
1977
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Abstract
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.
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openalex_W2127151679 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Stuart Pocock
Journal jurnal biometrika dan kependudukan
Year 1977
DOI
10.1093/biomet/64.2.191
URL
https://doi.org/10.1093/biomet/64.2.191
Keywords Keywords not found

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