Drug Evaluation Committee Introduction of "Framework For FDAs Real World Evidence Program
Data Science Subcommittee
March 2020
The Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) has been providing a number of workshops on the technical aspects of using Real-World Data (RWD) through "Introduction to Database Research", "Recommendations for Pragmatic Trials", "Practical Use of Real World Data (RWD) Analysis" and "Recommendations for Sensitivity Analysis in Observational Studies (Practical Version)". In Japan, the use of Real-World Data (RWD) for post-marketing safety surveillance has also been introduced. In Japan, the use of RWD is becoming common in post-marketing safety surveillance and post-marketing surveillance. In addition, the ICH is currently working on GCP renovation, and as part of this, the use of Real World Evidence (RWE), which is evidence obtained using RWD, is about to be incorporated into the system for new drug applications for approval. Thus, the discussion on the use of RWD and RWE is shifting to when they are used for regulatory decision-making.
This report introduces, supplements, and delves into the Framework For FDAs Real World Evidence Program, published by the FDA in December 2018, to provide an overview of what decision makers, including the FDA as regulator, are looking for in RWE and the motivations for its use in pharmaceutical companies, in clinical development The purpose of this report is to help those involved in clinical development, strategy, and clinical trial planning at pharmaceutical companies understand what decision makers, including the regulatory authority, the FDA, want from RWE and why they use it.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation, Data Science Subcommittee
Task Force 1 Real-World Evidence Team
Introduction of "Framework For FDAs Real World Evidence Program" (3.8MB)
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