Monitoring a clinical trial with multiple hypotheses concerning the treatment effect on a single primary endpoint.

@article{Denne2001MonitoringAC,
  title={Monitoring a clinical trial with multiple hypotheses concerning the treatment effect on a single primary endpoint.},
  author={Jonathan S Denne and Gary G. Koch},
  journal={Statistics in medicine},
  year={2001},
  volume={20 19},
  pages={2801-12; discussion 2813-4}
}
In a number of clinical trials there is interest in testing more than one hypothesis concerning the treatment effect on a single primary endpoint. For instance, a sponsor of a trial to demonstrate that a test treatment (T) is non-inferior to an active control (R) may also be interested in showing that T is superior to R, if this is the case. Using the closed testing method for constructing tests of multiple hypotheses which control the multiple level of significance, we provide a framework for… CONTINUE READING