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

Produced on behalf of

The Biometrika Trust

5-Yr impact factor: 2.373

Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.

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
Book (Wiley-Interscience)
  • Example Bullet Point 1
  • Example Bullet Point 2
Related Posts