Should Clinical Trials Be Allowed to Happen Outside Traditional Research Centres?
Official title: Consultation: Draft guidance on decentralized clinical trials
Health Canada wants feedback on new rules for "decentralized" clinical trials. These are drug studies where patients can participate from home or local clinics instead of travelling to major research hospitals. The draft guidance explains how researchers can use video calls, wearable devices, and home visits to run trials while still meeting safety standards.
Why This Matters
Ever been asked to join a clinical trial but couldn't because the research centre was too far away? This could change that. Decentralized trials let patients participate from home or nearby clinics. If you live in a rural or remote area, this could mean access to cutting-edge treatments without constant travel to big cities.
What Could Change
New guidance would officially allow researchers to conduct parts of clinical trials remotely. Drug companies could use video consultations, mail-in samples, and wearable health monitors instead of requiring in-person visits. This could speed up drug development and make Canada more attractive for international research.
Key Issues
- What regulatory safeguards are needed when trial activities happen outside traditional research centres?
- How can digital health technologies be used safely in clinical trials?
- How can decentralized trials improve access for patients in remote areas?
How to Participate
- Review the draft guidance document on decentralized clinical trials to understand the proposed regulatory approach.
- Send your feedback by email to bpsip-bpspiconsultation@hc-sc.gc.ca by the deadline.
- Alternatively, mail your written comments to Health Canada at the address provided in the contact section.