LATAM DCT Overview
- 9 Mins to read
- DarkLight
LATAM DCT Overview
- 9 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
Decentralized Clinical Trials - Overview
LATAM
The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.
| Version Number | Content Creation Date | Publishing Date | Section(s) Updated & Reason(s) for Update |
|---|---|---|---|
| V0 | 08 March 2024 | 11 March 2024 | N/A (new report) |
Disclaimers
A) At RegASK, we are committed to providing our clients with the most up-to-date and accurate information on regulatory requirements and compliance. To ensure the highest level of accuracy and relevance, we regularly review and update our e-guidebooks at least twice per year to reflect the latest regulatory developments in the market. (Please contact us if you wish to activate this feature.) In the meantime, our RegAlerts service is designed to keep our clients notified of any regulatory updates that may impact their business.
B) The contents on this platform are exclusively intended for the use of RegASK and its authorized representatives. All materials herein are confidential and the sole property of RegASK. Any reproduction, distribution, or display of this content to others is strictly prohibited without the express written consent of RegASK.
1. Assessment
Details of which countries allow eConsent are listed below:
Country Name | Is eConsent allowed? |
Argentina | Yes |
Bolivia | No |
Brazil | Yes |
Chile | No |
Colombia | Yes |
Costa Rica | No |
Dominican Republic | No |
Ecuador | No |
El Salvador | No |
Guyana | No |
Guatemala | No |
Honduras | No |
Mexico | No |
Nicaragua | No |
Panama | No |
Paraguay | No |
Peru | No |
Uruguay | No |
Venezuela | No |
Acceptance of eConsent is limited to 3 major markets in Latin America at the current time.
The reasons for a lack of acceptance of eConsent are not all regulatory-related but relate to socio-cultural issues in these countries and the nature of their health systems. This has resulted in a lack of acceptance by regulators and ethics committees. Overall, there are already a number of issues with informed consent as a whole which is potentially why it has not progressed as quickly as in other regions. These issues include:
- Lack of sophisticated regulatory systems
- General issues with compliance and adherence to consent requirements
- Cultural issues relating to the provision of consent (skepticism, unwillingness to sign particularly in indigenous populations)
- Low socioeconomic conditions and lack of literacy
- Slow adoption of technology
- The very small number of clinical studies conducted every year
2. Colombia
2.1 Do the country regulations allow a Decentralized Clinical Trial (DCT) Model e.g. eICF, ePROs administration, remote investigator site, etc?
Yes. In principle, there is nothing to prevent the implementation of a DCT model in Colombia. 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.
2.2 Is there any specific guidance on the use of DCT elements within a clinical trial?
No. There is no specific guidance on the conduct of decentralized trials.
2.3 What is the overall acceptability of DCT elements by the regulatory authorities and ethics committees?
In general, aspects of decentralization are accepted 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.
2.4 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)
There is no evidence to suggest that a fully decentralized trial has yet been conducted in Colombia.
2.5 Are there any non-regulatory DCT initiatives in the country, such as where investigator sites and local CROs founded an alliance?
No.
2.6 Are there any general considerations when using DCT elements in a study?
At this time, there are no specific considerations relevant to DCTs.
- Considerations/Requirements for the use of eConsent/Remote Consent
The use of eConsent/Remote Consent is acceptable according to the INVIMA regulations, subject to ethics approval.
- Considerations/Requirements for the use of eSignatures
There is no specific guidance on the use of eSignatures in clinical trials. In general, eSignatures are legally accepted in Colombia and are subject to Law 527 of 1999.
- 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 the RA and ethics committee.
- Considerations/Requirements for HHC - Home Nursing
There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.
- 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 the RA and ethics committee.
- Considerations/Requirements for the Use of Telemedicine
Telemedicine is an accepted practice in Colombia. Regulations first came into place in 2007 and have been further defined over the years to allow for the use of electronic platforms. There are no restrictions on the nature of health services that can be provided through telemedicine. The systems to be used must assure the confidentiality of patient information and the security of any data recorded by the platform.
- 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 the RA and ethics committee.
- Considerations/Requirements for Remote Monitoring
There are no specific guidelines on what is acceptable – however, this is allowed under the provisions for telemedicine.
- Considerations/Requirements for Digital Health Technologies (such Platforms)
There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.
3. Chile
3.1 Do the country regulations allow a Decentralized Clinical Trial (DCT) Model e.g. eICF, ePROs administration, remote investigator site, etc?
Yes. In principle, there is nothing to prevent the implementation of a DCT model in Chile. 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.
3.2 Is there any specific guidance on the use of DCT elements within a clinical trial?
No. There is no specific guidance on the conduct of decentralized trials.
3.3 What is the overall acceptability of DCT elements by the regulatory authorities and ethics committees?
In general, aspects of decentralization are accepted 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.
3.4 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)
There is no evidence to suggest that a fully decentralized trial has yet been conducted in Chile.
3.5 Are there any non-regulatory DCT initiatives in the country, such as where investigator sites and local CROs founded an alliance?
No.
3.6 Are there any general considerations when using DCT elements in a study?
At this time, there are no specific considerations relevant to DCTs.
- Considerations/Requirements for the use of eConsent/Remote Consent
The use of eConsent/Remote Consent is not currently accepted. Paper-based systems still apply.
- Considerations/Requirements for the use of eSignatures
There is no specific guidance on the use of eSignatures in clinical trials. In general, eSignatures are legally accepted in Chile and are subject to Law No. 19.799 and Decree 181/2002.
- 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 the RA and ethics committee.
- Considerations/Requirements for HHC - Home Nursing
There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.
- 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 the RA and ethics committee.
- Considerations/Requirements for the Use of Telemedicine
Telemedicine is an accepted practice in Chile. Its implementation was fast-tracked in 2020 in response to the COVID-19 pandemic and these practices remain in place to support the provision of services to patients, especially in remote locations.
- 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 the RA and ethics committee.
- Considerations/Requirements for Remote Monitoring
There are no specific guidelines on what is acceptable – however, this is allowed under the provisions for telemedicine.
- Considerations/Requirements for Digital Health Technologies (such Platforms)
There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.
4. Peru
4.1 Do the country regulations allow a Decentralized Clinical Trial (DCT) Model e.g. eICF, ePROs administration, remote investigator site, etc?
Yes. In principle, there is nothing to prevent the implementation of a DCT model in Peru. 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.
4.2 Is there any specific guidance on the use of DCT elements within a clinical trial?
No. There is no specific guidance on the conduct of decentralized trials.
4.3 What is the overall acceptability of DCT elements by the regulatory authorities and ethics committees?
In general, aspects of decentralization are accepted 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.
4.4 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)
There is no evidence to suggest that a fully decentralized trial has yet been conducted in Peru.
4.5 Are there any non-regulatory DCT initiatives in the country, such as where investigator sites and local CROs founded an alliance?
No.
4.6 Are there any general considerations when using DCT elements in a study?
At this time, there are no specific considerations relevant to DCTs.
- Considerations/Requirements for the use of eConsent/Remote Consent
The use of eConsent/Remote Consent is not currently accepted. Paper-based systems still apply.
- Considerations/Requirements for the use of eSignatures
There is no specific guidance on the use of eSignatures in clinical trials. In general, eSignatures are legally accepted in Peru and are subject to Law No. 27269 and Supreme Decree No. 052-200-PCM.
- 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 the RA and ethics committee.
- Considerations/Requirements for HHC - Home Nursing
There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.
- 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 the RA and ethics committee.
- Considerations/Requirements for the Use of Telemedicine
Telemedicine is an accepted practice in Peru. Its implementation commenced in 2005 but was very limited in nature and was fast-tracked in 2020 in response to the COVID-19 pandemic and these practices remain in place to support the provision of services to patients, especially in remote locations.
- 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 the RA and ethics committee.
- Considerations/Requirements for Remote Monitoring
There are no specific guidelines on what is acceptable – however, this is allowed under the provisions for telemedicine.
- Considerations/Requirements for Digital Health Technologies (such Platforms)
There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.
Conclusion & Recommended Next Steps
Generally, the implementation of decentralized clinical trials is slower in LATAM than in other regions of the world. The reasons for this are varied and relate to both sociocultural issues and a lack of the required infrastructure. As a consequence, the number of countries that accept technological advances such as eConsent is very limited.
5. References
https://www.ispch.gob.cl/anamed/
3. National Institute of Health, Peru
4. Drug Utilization Studies in Latin America: A Scoping review and Survey of Ethical Requirements
https://www.sciencedirect.com/science/article/pii/S2212109918302334
Was this article helpful?