7. Decentralized Clinical Trials

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)?

Yes. In principle, there is nothing to prevent the implementation of a DCT model in Japan. The specific elements of decentralization to be included in a trial are subject to ethics approval depending on the nature of the study and the level of risk.

7.2 Is there any specific regulation/guidance on the use of DCT elements within a clinical trial?

No. There is no specific guidance on the conduct of decentralized trials in Japan. However, PMDA has presented the use of ICT to facilitate clinical trials. 

https://www.pmda.go.jp/files/000248622.pdf

7.3 What is the overall acceptability of DCT elements by the regulatory authorities and Ethics Committees?

In general, PMDA and ethics committees are accepting of the adoption of DCT elements within clinical trials. The use of DCT elements increased during the COVID-19 pandemic and they continue to be used in studies to enhance patient experience and to access patients in remote areas.

7.4 Has a fully virtual trial (DCT) been conducted in the country yet? If so, please provide an example including the registration number and any link to it, whether COVID/non-COVID trials.

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.

7.5 Are there any non-regulatory DCT initiatives in the country, such as where the investigator sites and local CROs founded an alliance?

No.

7.6 Are there any general considerations when using DCT elements in a study?

Please refer to Section 7.2 above. 

Additionally, Sponsors should be mindful that electronic signatures are not permitted for Informed Consent. 

7.7 Considerations/Requirements for the Use of eConsent/Remote Consent

Informed consent must be recorded with wet signatures. 

7.8 Considerations/Requirements for the Use of eSignatures

Japan has recognized e-signatures as a legal form of signing since 2000, giving businesses the option to use them whilst trading.

According to the Act on Electronic Signatures and Certification Business (Electronic Signature Act), “electronic signature” means:

A measure to be taken with respect to information that can be recorded in an electromagnetic record (a record that is prepared in an electronic form, a magnetic form, or any other form not perceivable by human senses and used for information processing by computers), which measure satisfies both of the following requirements:

• The measure must indicate that such information was created by the person who took such measure; and
• The measure must be able to confirm that such information has not been altered.

It is to be noted that eSignatures are not allowed to be used in the informed consent form (ICF). In these documents, wet signatures are to be used.

7.9 Considerations/Requirements for Electronic Patient Reported Outcome (ePRO)

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by PMDA and the ethics committee.

7.10 Considerations/Requirements for Home Health Care (HHC) - Home Nursing

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by PMDA and the ethics committee.

7.11 Considerations/Requirements for HHC- Home Lab Collection

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by PMDA and the ethics committee.

7.12 Considerations/Requirements for Direct-to-Patient Study Product Delivery

Sponsors are typically required to provide IMP to patients directly. Alternative means of product supply would be subject to ethics approval. 

7.13 Considerations/Requirements for the Use of Telemedicine

Teletrials are generally accepted in Japan. Sponsors must decide upfront about the approach to monitoring and they must include this in the protocol. Remote monitoring has become more accepted as a consequence of the COVID-19 pandemic. 

7.14 Considerations/Requirements for the Use of Wearables

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by PMDA and the ethics committee.

7.15 Considerations/Requirements for Remote Monitoring

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by PMDA and the ethics committee.

7.16 Considerations/Requirements for Digital Health Technologies (such as Platforms)

There are no specific guidelines on what is acceptable –  this forms part of the review and assessment by PMDA and the ethics committee.