1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in Japan in relation to Decentralized Clinical Trials (“DCT”). Clinical Trials are governed in Japan by the Pharmaceutical and Medical Device Agency (PMDA) with additional oversight provided at an institutional level by Independent Review Boards (IRBs). 

The conduct of Japan’s first fully decentralized clinical trial was reported in July 2023. Trial WJOG15221M was a phase 2 open-label study investigating an oral anticancer treatment in patients with ALk fusion-positive tumors. The PMDA is receptive to new ways of conducting assessments and patient monitoring including the adoption of technology.