Information-based monitoring of clinical trials.

  title={Information-based monitoring of clinical trials.},
  author={Anastasios A. Tsiatis},
  journal={Statistics in medicine},
  volume={25 19},
  pages={3236-44; discussion 3320-5, 3326-47}
When designing a clinical trial to compare the effect of different treatments on response, a key issue facing the statistician is to determine how large a study is necessary to detect a clinically important difference with sufficient power. This is the case whether the study will be analysed only once (single-analysis) or whether it will be monitored periodically with the possibility of early stopping (group-sequential). Standard sample size calculations are based on both the magnitude of… CONTINUE READING