Challenge of multiple co-primary endpoints: a new approach.

  title={Challenge of multiple co-primary endpoints: a new approach.},
  author={Christy Chuang-Stein and Paul Stryszak and Alex Dmitrienko and Walter W. Offen},
  journal={Statistics in medicine},
  volume={26 6},
There are many disorders where regulatory agencies have required a new treatment to demonstrate efficacy on multiple co-primary endpoints, all significant at the one-sided 2.5 per cent level, before accepting the treatment's effect for the disorder. This requirement, rooted in the intersection-union (IU) test, has led many researchers to increase the study sample size to make up for the reduction in the statistical power at the study level. Unfortunately, the increase in sample size could be… CONTINUE READING

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