The Update of the Regulations on Decentralized Clinical Trials in Japan : Especially on the e-consent Guidance

Abstract

Decentralized clinical trial (DCT) is expected to have various added values, such as ensuring patient’s easy access to clinical trials regardless of their circumstances, in addition to efficient conduction of clinical trials. With the significant advancement of information and communication technology, DCT is being introduced worldwide in development of new therapeutics. In order to strengthen Japan’s drug discovery capabilities and to promote the introduction of therapeutics with highly medical needs, it is necessary to develop a domestic clinical trial environment, through incorporating new technologies such as DCT. This article outlines the recent updates of pharmaceutical regulations surrounding DCT in Japan, focusing on the guidance for online informed consent (e-consent) issued by the Ministry of Health, Labor and Welfare in March 2023, as part of efforts to promote DCT. The guidance indicates the points to be considered for e-consent, including identity verification methods, privacy protection of subjects, communication methods, use of videos, electronic signatures, etc.