JPMA Committee Activities CTD Structure Using the Results of Multi-Regional Clinical Trials Based on the Principles in ICH E17
The ICH E17 Guideline on "General Principles for Planning and Design of Multi-Regional Clinical Trials" reached ICH Step 4 agreement in 2017 and MHLW's Notification (Step 5) was issued in Japan in 2018. Currently, many Multi-regional Clinical Trials (MRCTs) have been conducted, and many drugs have been approved for marketing based on the results. However, few Common Technical Documents (CTD) are prepared based on ICH E17 and most CTD are written from a “local-first” concept based on ICH E5, which focuses on the results in the application country/region first, and then evaluates the similarity with other regions or the whole study.
This report intends to deepen the understanding of multifaceted and systematic evaluation methods based on the principles of ICH E17, and proposes a method to evaluate the results of MRCT and to prepare CTD using a framework of the 3-layer approach proposed by Komiyama et al.
We hope that this report would be of help to the interpretation of MRCT results and the preparation of CTD based on the principles in ICH E17.
FY2022 Task Force 2-2,
Data Science Expert Committee,
Drug Evaluation Committee
Note: Komiyama O, Hiro S, Isogawa N, et al. (2013) Evaluation of Data for Multi-Regional
Trials: A Three-Layer Approach. Applied clinical trials, vol 22, Issue 11.