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 are no regulations preventing the conduct of a DCT.

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

There is no guidance available.

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

DCTs are not explicitly prevented. However, there is little to no guidance regarding DCTs or the use of 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.

There is no evidence that a fully decentralized trial has been conducted in Mexico.

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.

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

eConsent is not yet accepted in Mexico.

7.8 Considerations/Requirements for the Use of eSignatures

Electronic signatures are recognized in Mexico in general and may be used for non-critical trial materials (but not for critical documents such as the ICF).

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

The adoption of technology has been slow in Mexico and hard-copy records are still favored.

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

Home nursing for clinical trials has not been readily adopted in Mexico.

7.11 Considerations/Requirements for HHC - Home Lab Collection

Home lab collection for clinical trials has not been readily adopted in Mexico.

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

Wearables for clinical trials have not been readily adopted in Mexico.

7.13 Considerations/Requirements for the Use of Telemedicine

Telemedicine for clinical trials has not been readily adopted in Mexico.

7.14 Considerations/Requirements for the Use of Wearables

Wearables for clinical trials have not been readily adopted in Mexico.

7.15 Considerations/Requirements for Remote Monitoring

Remote monitoring for clinical trials has not been readily adopted in Mexico. 

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

Digital health technologies are not widely accepted in Mexico.