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Group sequential designs clinical trials

SUMMARYIn 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.

  1. Biometrika (1977) 64 (2): 191-199. doi: 10.1093/biomet/64.2.191

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

Wiley-Interscience Bayesian Methods and Ethics in a Clinical Trial Design
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