2024-08-02 16:20:00
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Clinical trials, including expanded access clinical trials, can sometimes provide studies of the use of new treatments before Health Canada authorizes them for sale. These may include treatments for serious or life-threatening conditions for which authorized medicines may be restricted to certain patients (e.g., in the areas of oncology, rare diseases, and certain psychiatric disorders).
Health Canada has developed draft guidance to expand access to clinical trials. This article highlights a mechanism that already exists, provides additional information about it, and may be relevant to clinical trial sponsors, healthcare providers, and patients.
Regulatory requirements are described in Part C, Title 5 (Drugs for use in human clinical trials) food and drug regulations. Because regulations already support the conduct of expanded access clinical trials, the draft guidance will come into effect after the consultation is launched.
About expanding clinical trials
An expanded access clinical trial is a type of clinical trial that provides the opportunity to study drugs that may treat people with:
Not eligible or unable to participate in other clinical trials
Expanded clinical trials could be designed for larger and potentially more diverse participant groups in more accessible settings. As a result, they could provide better access to experimental drugs for certain patients who could benefit from treatment.
How to participate
We welcome your comments on the draft guidance.
We will consider all written submissions after the consultation period, which ends on 31 October 2024. Your comments will be made public in the What We Hear report and will be considered when the guidance is finalized. This final version will be developed as part of Health Canada’s Clinical Trials Regulatory Modernization Program.
learn more:
contact us
Office of Policy, Science and International Programs
The Goods Administration
Health Products and Food Branch
health canada
1600, Scott Street
Dutch Cross, Section B
Address index: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca
1722787023
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