PROCOVA™ Handbook for the Target Trial Statistician

The European Medicines Agency has released a final qualification opinion on our 3-step PROCOVA™ procedure for Phase 2 or 3 TwinRCTs™. To help target trial statisticians understand how to implement PROCOVA, we’ve created this handbook which provides a brief overview of the methodology and instructions covering 1) how to validate the prognostic score generated by a prognostic model for use in a particular planned trial, 2) how to estimate the sample size and plan the Target Trial using PROCOVA for the primary analysis, 3) how to estimate the treatment effect using a linear model while adjusting for the prognostic score and assess a null hypothesis by computing a two-sided p-value based on a t-distribution.

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Summary of the EMA September 2022 Qualification Opinion for PROCOVA™


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