Health Canada summarizes feedback on Draft Guidance for Decentralized Clinical Trials
Health Canada has published a report summarizing key comments received during the public consultation on future guidance for Decentralized Clinical Trials (DCTs), covering topics such as digital technologies, oversight, risk management, and participant access.
Health Canada has published the report “What We Heard: Draft Guidance on Decentralized Clinical Trials”, which summarizes feedback received during the public consultation on the future guidance for Decentralized Clinical Trials (DCTs).
The consultation gathered input from various stakeholders, including:
Clinical research organizations;
Healthcare and academic institutions;
Pharmaceutical industry associations;
Professional associations;
Patient advocacy organizations.
What are Decentralized Clinical Trials?
Decentralized Clinical Trials (DCTs) allow certain clinical trial activities to be conducted outside traditional research sites.
According to Health Canada, this approach can:
Improve access to clinical trials;
Increase participant diversity;
Facilitate participation from rural and remote communities;
Support participant retention throughout the study.
Key topics identified
1. International alignment
Participants recommended greater harmonization with international guidance, including:
International Council for Harmonisation (ICH);
U.S. Food and Drug Administration (FDA);
European Medicines Agency (EMA).
Stakeholders also requested additional clarification on digital technologies used in clinical trials.
2. Risk-based regulatory approach
Stakeholders advocated for a risk-proportionate approach to different decentralized elements of clinical trials.
They also requested additional guidance on:
Documentation;
Monitoring;
Validation of computerized systems;
Risk management.
3. Operational implementation
Several practical challenges were identified, including:
Local contracts;
Training of healthcare professionals;
Investigational product logistics;
Record retention;
Use of digital platforms.
Additional concerns were raised regarding:
Data interoperability;
Cybersecurity;
Vendor oversight;
Cross-border information flows.
4. Oversight and responsibilities
Participants requested greater clarity regarding:
Sponsor responsibilities;
Investigator responsibilities;
Delegation of activities;
Oversight models;
Inspection boundaries.
5. Equity and digital access
Comments highlighted the need for:
Flexible informed consent options;
Participant privacy protection;
Mitigation of digital barriers;
Promotion of more equitable access to clinical trials.
Impact for medical device and IVD manufacturers
Although the consultation focused on decentralized clinical trials, stakeholder feedback included several topics related to digital health technologies and software used in clinical research.
Topics mentioned include:
Software as a Medical Device (SaMD);
Validation of computerized systems;
Data interoperability;
Cybersecurity;
Vendor oversight;
Cross-border data flows.
Stakeholders also requested greater clarity on situations where software or electronic patient-reported outcome devices used in clinical trials may be considered medical devices and when a Medical Device Investigational Testing Authorization may be required.
Next steps
Health Canada stated that the feedback received will be considered during the revision and finalization of the guidance. The draft guidance will remain available as a reference document until the modernized clinical trial regulatory framework comes into force.
Read the full draft guidance below.
