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.)?

There is nothing preventing the conduct of a decentralized trial in Thailand, pending approval of the trial by the EC.

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

Thailand has no specific guidance yet regarding DCTs.

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

Post-COVID, there has been increasing acceptance of DCT elements in clinical trials. These are accepted through EC approval.

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.

In June 2023, a cross-border Decentralized Trial between patients in Thailand and Japan was reported. Patients in Thailand were involved in a cancer study which was being run by a Japanese hospital. This indicates that Thai Ethics committees are open to the use of DCT elements. 

https://www.ncc.go.jp/en/information/press_release/20230627/index.html

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, there are no local initiatives around DCTs. 

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

At this time, there are no guidelines specific to DCTs.

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

There are no specific requirements preventing the use of eConsent.

7.8 Considerations/Requirements for the Use of eSignatures

eSignatures are legal in Thailand for Life Sciences. As per the links below, there is no requirement for a countersignature.

https://www.docusign.com/products/electronic-signature/legality/thailand 

https://www.hellosign.com/esignature-legality/thailand 

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

There is no regulation preventing the use of ePro in Thailand subject to RA/EC approval.

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

At-home nursing is becoming more common in Thailand.

7.11 Considerations/Requirements for HHC - Home Lab Collection

There is no specific guidance around home lab collection for clinical trials.

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

No, subjects can't purchase marketed products. In Thailand, any product to be used in a clinical trial needs to be provided in a controlled manner via the sponsor.

7.13 Considerations/Requirements for the Use of Telemedicine

There is no specific guidance around Telemedicine.

7.14 Considerations/Requirements for the Use of Wearables

There is no specific guidance around the use of Wearables.

7.15 Considerations/Requirements for Remote Monitoring

There is no specific guidance around remote monitoring.

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

During the COVID-19 pandemic, the use of remote assessments has become more common, but this is still not commonplace for other trials.