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.

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