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A Pilot Study on the Feasibility of Using P-Plots for Signal Detection in Pharmacovigilance

Pharmacovigilance signal detection algorithms commonly involve the calculation of observed/expected (O/E) reporting frequencies, ratios, or odds calculated from 2×2 contingency tables. Frequentist and Bayesian implementations each have strengths and limitations. No single approach has emerged as universally superior. P-plots are a graphically oriented, frequentist statistical methodology based on the distributional properties of p-values as random variables under the null versus alternative hypotheses. This leads to our current assessment of the feasibility and performance of P-plots as a novel alternative or augmentation in quantitative pharmacovigilance signal detection methodology.