Health Canada updates the guidance on expanded access clinical trials: Notice
On this page
- Background
- About expanded access clinical trials
- Consultation process
- What changed in the guidance
- What’s next
- Contact us
Background
Health Canada has updated the guidance on expanded access clinical trials to make the information about the current process clearer.
The rules for drugs used in clinical trials involving people are set out in Part C, Division 5 of the Food and Drug Regulations. Since the regulations already support expanded access clinical trials, the updated guidance takes effect immediately.
About expanded access clinical trials
In Canada, an expanded access clinical trial is a type of clinical trial that provides access to investigational drugs that have the potential to treat people living with medical conditions who don’t qualify for other trials or can’t take part in them.
Expanded access clinical trials can be designed for a larger, potentially more diverse population of participants, in more accessible settings.
In some cases, these trials allow access to investigational drugs before they’re officially approved for sale in Canada, but only if the expected benefits outweigh the risks. This might include treatments for serious mental health conditions or life-threatening illnesses where approved options aren’t suitable for some patients.
Consultation process
We released the draft guidance on August 2, 2024, and accepted public feedback until October 31, 2024. We received 21 submissions from a range of stakeholders during this period.
For a summary of the feedback, visit What we heard: Draft guidance on expanded access clinical trials.
What changed in the guidance
We made changes based on the feedback we received to make the process clearer for starting, running or joining an expanded access clinical trial in Canada.
For example, we:
- improved readability and flow, especially in the first part of the guidance
- added a glossary to define important terms
- clarified some sections, including:
- the purpose and benefits of expanded access clinical trials
- how to submit or amend a clinical trial application
- how Canada’s approach differs from international approaches
- the reporting requirements
- how evidence is collected and evaluated
What’s next
Many people who reviewed the draft guidance expressed support for decentralized clinical trials. As any type of clinical trial, including an expanded access clinical trial, can use a decentralized model, we are working on new standalone guidance for decentralized clinical trials.
We expect this new guidance will be open for public consultation in fall 2025. To avoid repetition, we shortened the section on decentralization in this updated guidance on expanded access clinical trials.
A notice will be posted on our consultation webpage in the future for those interested in reviewing the new guidance for decentralized clinical trials
We also received more general comments about Canada's clinical trials system. These comments will help inform future work, such as the Clinical Trials Modernization Initiative.
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: policy_bureau_enquiries@hc-sc.gc.ca