Idle thoughts of a 'well-calibrated' Bayesian in clinical drug development

Pharmaceutical Statistics
Andrew P Grieve

Abstract

The use of Bayesian approaches in the regulated world of pharmaceutical drug development has not been without its difficulties or its critics. The recent Food and Drug Administration regulatory guidance on the use of Bayesian approaches in device submissions has mandated an investigation into the operating characteristics of Bayesian approaches and has suggested how to make adjustments in order that the proposed approaches are in a sense calibrated. In this paper, I present examples of frequentist calibration of Bayesian procedures and argue that we need not necessarily aim for perfect calibration but should be allowed to use procedures, which are well-calibrated, a position supported by the guidance. Copyright © 2016 John Wiley & Sons, Ltd.

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Citations

Oct 13, 2016·Pharmaceutical Statistics·Andrew P Grieve
Dec 30, 2017·Statistical Methods in Medical Research·Anja BertscheGerhard Nehmiz
Jun 27, 2018·Pharmaceutical Statistics·David Morgan
Sep 4, 2018·Biometrical Journal. Biometrische Zeitschrift·Annette Kopp-SchneiderUlrich Abel
Oct 17, 2018·Biometrical Journal. Biometrische Zeitschrift·Isaac Gravestock, Leonhard Held
Jan 18, 2019·Statistics in Medicine·Tim P MorrisMichael J Crowther
Jul 3, 2019·Biometrical Journal. Biometrische Zeitschrift·Annette Kopp-SchneiderManuel Wiesenfarth
Dec 13, 2018·Evaluation Review·Lauren VollmerRandall Brown
Jan 20, 2021·Pharmaceutical Statistics·Chuanwu ZhangByron J Gajewski
Feb 24, 2021·Pharmaceutical Statistics·Rosalind J Walley, Andrew P Grieve

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