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Inference and Decision Making for 21st-Century Drug Development and Approval

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Listed:
  • Stephen J. Ruberg
  • Frank E. Harrell
  • Margaret Gamalo-Siebers
  • Lisa LaVange
  • J. Jack Lee
  • Karen Price
  • Carl Peck

Abstract

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value

Suggested Citation

  • Stephen J. Ruberg & Frank E. Harrell & Margaret Gamalo-Siebers & Lisa LaVange & J. Jack Lee & Karen Price & Carl Peck, 2019. "Inference and Decision Making for 21st-Century Drug Development and Approval," The American Statistician, Taylor & Francis Journals, vol. 73(S1), pages 319-327, March.
    • Handle: RePEc:taf:amstat:v:73:y:2019:i:s1:p:319-327
    DOI: 10.1080/00031305.2019.1566091
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