Planned versus attained design in phase II clinical trials.

  title={Planned versus attained design in phase II clinical trials.},
  author={Stephanie J. Green and Steve Dahlberg},
  journal={Statistics in medicine},
  volume={11 7},
The standard phase II trial problem is to decide whether or not to continue the testing of a new agent (or combination). Typically, one tests the null hypothesis HO: p = pO against the alternative HA: p = pA, where p is the probability of response. There is available a variety of two-stage phase II designs, including optimal designs according to various criteria. Practical considerations in the conduct of multicentre trials, however, make it difficult to follow designs precisely. We investigate… CONTINUE READING