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 no evidence for the conduct of DCTs in Indonesia to date. As a whole, the conduct of clinical trials is quite limited with a strong focus on locally developed products. 

Healthcare infrastructure in Indonesia, including the adoption of technology, is modest and the healthcare system is not well placed to adopt progressive approaches such as DCTs. 

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

As there are currently no DCT elements present in trials, there isn’t guidance available for the use of these elements.

7.3 What is the overall acceptability of DCT elements by the Regulatory Authorities and Ethics Committees?

DCT elements aren’t discouraged. However, clinical trials in Indonesia haven’t presented any DCT elements as of yet; their lack of technological infrastructure in healthcare discourages many DCT elements.

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.

No. There is no evidence that a fully decentralized trial has taken place.

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?

No. There are no guidelines relating to DCTs. 

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

eConsent is currently not permitted. Wet signatures are required.

7.8 Considerations/Requirements for the Use of eSignatures

eSignatures are currently not permitted. Wet signatures are required. 

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

eRegulatory programs are being standardized throughout Indonesia. Several hospitals in Indonesia are now participating in a pilot program and establishing guidelines on how to secure data and then create standardized electronic medical records that can be protected. However, these are not being used widely yet.

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

Home nursing is legal in Indonesia. However, there are no clinical trials that have included Home Nursing yet; therefore, this will be a part of the ethics approval process.

7.11 Considerations/Requirements for HHC - Home Lab Collection

Home lab collection is not yet used in Indonesia.

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

Direct-to-patient study product delivery is not commonly employed in Indonesia.

7.13 Considerations/Requirements for the Use of Telemedicine

In order to upgrade the quality of healthcare services in Indonesia, especially with regard to services for patients in remote areas, the government has opened up the possibility of telemedicine healthcare services by issuing MOH Regulation 20. Pursuant to MOH Regulation 20, telemedicine services can be organized on the basis of collaboration between health service facilities (‘HSF’).

MOH Regulation 20 defines telemedicine as the provision of long-distance health services by health professionals by utilizing information and communication technology, consisting of information exchange on diagnosis, medication, disease and injury prevention, research and evaluation, and sustainable education of health service providers in order to improve individual and public health.

The telemedicine services shall consist of teleradiology, tele-electrocardiography, tele-ultrasonography, teleconsultation clinic service, and other services in accordance with the development of science and technology. The telemedicine services are implemented by health workers who hold practice licenses in the organizing HSF.

The use of telemedicine is currently very limited but there is the potential that this will open up usage in clinical trials. 

7.14 Considerations/Requirements for the Use of Wearables

Wearables are permitted in Indonesia. However, at this time, there is no specific guidance on this matter. As the digital health space opens up in Indonesia, it is likely they will become more accepted in clinical trials.

7.15 Considerations/Requirements for Remote Monitoring

Remote monitoring is not widely used in Indonesia yet.

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

Presently, Digital Health technologies aren't prevalent in Indonesian healthcare.