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

Stephen J. Ruberg, Frank E. Harrell, Margaret Gamalo-Siebers, Lisa LaVange, J. Jack Lee, Karen Price and Carl Peck

The American Statistician, 2019, vol. 73, issue S1, 319-327

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

Date: 2019
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DOI: 10.1080/00031305.2019.1566091

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