Summary of the EMA March 2022 Draft Qualification Opinion for PROCOVA™

As of September 2022, this draft qualification opinion has been published by the European Medicines Agency (EMA) as a final qualification opinion, which can be found here.

In March of 2022, the EMA released a draft qualification  opinion on our PROCOVA™ procedure. The draft opinion provides the regulatory framework for planning and conducting a Phase 2 or 3 TwinRCT™,  which leverages historical data and machine learning to reduce sample sizes  in clinical trials. This summary provides the following (1) highlights the  most important sections of the draft qualification opinion, (2) reviews the  critical elements of the PROCOVA™ procedure, and (3) addresses FAQs about  the draft opinion and supporting documents.

To help target trial statisticians understand how to  implement PROCOVA™, we've created this handbook, PROCOVA™ Handbook for the Target Trial  Statistician. This document provides step-by-step guidance for the  practical application of PROCOVA™ following a brief overview of the  methodology.