Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

@article{Dallas2008AccountingFI,
  title={Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.},
  author={Michael J. Dallas},
  journal={Journal of biopharmaceutical statistics},
  year={2008},
  volume={18 4},
  pages={631-8; discussion 439-45}
}
Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive… CONTINUE READING