JPMA Committee Activities Drug Evaluation From Now On --- What's the value of local data in the global clinical data package?
The ICH E17 Guideline on "General Principles for the Planning and Design of Multi-Regional Clinical Trials" reached ICH Step 4 agreement in 2017 and a notification was issued in Japan (Step 5) in 2018. However, its application does not seem to be widespread. In this report, we attempted to carefully explain the "scientific concept" underlying the ICH E17 Guideline in order to move forward into the future in light of the current situation where global simultaneous development has become a mainstream strategy. And we also discussed how drug evaluation should be from now on, without limiting to the context of the ICH E17.
We considered "drug evaluation" as a learning process to understand the efficacy and safety of a drug, and discussed what kind of thinking should be applied to drug evaluation from the development to the post-marketing stage. We have come to the conclusion that a new axis of thinking is to deepen our understanding of "factors affecting treatment effects", i.e., effect modifiers. We believe that thinking based on effect modifiers can be applied not only to global development, but also to drug development under various circumstances, such as drug development for rare diseases and special patient populations.
We hope that this report would be of help to all those involved in drug development, and that it could provide a foundation for the thinking of the next generation of drug developers.
FY2020 Task Force 5,
Data Science Expert Committee,
Drug Evaluation Committee