P‐values and decision‐making: discussion of ‘Limitations of empirical calibration of p‐values using observational data’

Gruber and Tchetgen Tchetgen bring up many important limitations of p-value calibration as applied to the assessment of the safety and effectiveness of medications in secondary administrative data. In this discussion, I further examine the role of study design and selection of comparators in interpreting p-value calibration results, and we consider the advantages and disadvantages of automation in the epidemiology of medications, including p-value calibration. Copyright © 2016 John Wiley & Sons, Ltd.

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