Should Clinical Trials Happen Outside Traditional Hospitals?
Official title: Consultation: Draft guidance on decentralized clinical trials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 traveling to major research centres. The goal? Make it easier for more Canadians to join medical research, especially those in remote areas.
Why This Matters
Ever been asked to join a clinical trial but couldn't because the research centre was hours away? This could change that. Decentralized trials let you participate through video calls, local blood draws, and wearable devices. It's especially important for people in rural or remote communities who've been left out of medical research.
What Could Change
New guidance would clarify how drug companies can run trials using telemedicine, home visits, and digital health tools. This could mean more trials recruiting in smaller communities. Researchers in remote areas could connect to national studies they couldn't access before.
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 participants in remote areas?
How to Participate
- Read the draft guidance document on decentralized clinical trials to understand the proposed rules.
- Email your feedback to bpsip-bpspiconsultation@hc-sc.gc.ca by the deadline.
- Or send a letter to Health Canada at the address provided in the contact section.