Drug Evaluation Committee Introduction of "Framework For FDAs Real World Evidence Program
March 2020
The Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association has previously published reports on the technical aspects of using Real-World Data (RWD) through the following publications: “Introduction to Database Research,” “A Guide to Pragmatic Trials,” “Practical Real-World Data Analysis: Let’s Explore RWD,” and “Recommendations for Sensitivity Analysis in Observational Studies: A Practical Guide.”In Japan as well, the use of RWD is becoming increasingly common in post-marketing safety surveillance and post-marketing studies. Furthermore, the ICH is currently advancing its GCP renovation efforts, and as part of this, the use of Real-World Evidence (RWE)—evidence derived from RWD—is being incorporated into the regulatory framework for new drug approval applications.Thus, the discussion surrounding the use of RWD and RWE is shifting toward their application in regulatory decision-making.
This report introduces the “Framework for the FDA’s Real-World Evidence Program,” published by the FDA in December 2018, and by supplementing andto help those involved in clinical development strategies and clinical trial planning at pharmaceutical companies understand what decision-makers—including the FDA as a regulatory authority—expect from RWE and their motivations for using it.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, Data Science Subcommittee
Task Force 1: Real-World Evidence Team
Introduction to “Framework for the FDA’s Real-World Evidence Program” (3.8MB)