Innovative approaches for designing and analyzing adaptive dose-ranging trials.

  title={Innovative approaches for designing and analyzing adaptive dose-ranging trials.},
  author={Bj{\"o}rn Bornkamp and Frank Bretz and Alex Dmitrienko and Greg Enas and Brenda L Gaydos and Chyi-Hung Hsu and Franz Koenig and Michael Krams and Qing Liu and Beat Neuenschwander and Tom Parke and Jos{\'e} Pinheiro and Amit Roy and Rick Sax and Frank Shen},
  journal={Journal of biopharmaceutical statistics},
  volume={17 6},
Inadequate selection of the dose to bring forward in confirmatory trials has been identified as one of the key drivers of the decreasing success rates observed in drug development programs across the pharmaceutical industry. In recognition of this problem, the Pharmaceutical Research and Manufacturers of America (PhRMA), formed a working group to evaluate and develop alternative approaches to dose finding, including adaptive dose-ranging designs. This paper summarizes the work of the group… CONTINUE READING

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