Health Canada Policy on the Registration of Clinical Trials and Public Disclosure of Results

By Tamara Schoyen

Health Canada (HC) reminds sponsors of their responsibilities and policy expectations for Canadian clinical trials that are regulated under the Food and Drugs Act and the Medical Devices Regulations (SOR/98-282) – Part 3 Medical Devices for Investigational Testing Involving Human Subjects. This comes five months after the U.S. Food and Drug Administration (FDA) contacted more than 2,200 sponsors and researchers (3,000 clinical investigations) to remind them of their clinical investigational responsibilities.  

Background

Similar to high-risk medical device clinical investigations in the U.S. and EU that need to be authorized by the regulators, clinical trials (referred to as investigational testing) for Class II-IV medical devices conducted in Canada involving human subjects must receive authorization from HC. 

New HC policy objectives

While there is a legislative requirement for the trial to be authorized in Canada, there is no corresponding requirement to register investigational testing in a database. To increase transparency of Canadian trials, sponsors are expected to register each clinical trial with a clinical trial registry that complies with the international standards set by the World Health Organization (WHO) — for example, ClinicalTrials.gov in the U.S. and ISRCTN in the U.K.

This facilitates public access to information on the clinical trials, including registration details, summary results reports and other publicly available study information.

Proposed timing for registration and reporting

HC recommends that registration occur before the clinical trial opens for enrollment in Canada, but not later than 21 calendar days after the date of enrollment of the first participant.

HC states that: 

• Results should be reported through the same registry in which the trial is registered.
• Summary results of the clinical trial should be submitted within 12 months following primary study completion. Primary study completion is defined as the final study visit at which primary outcome data are collected from the last participant in the global study.
• Clinical trial information should be kept up to date in the registry. This includes submitting any outstanding summary results information within one year of study completion (defined as the last participant's last visit).

HC public search portal for clinical trials

HC has created a public search portal to identify clinical trials conducted in Canada that are registered. The portal is not a registry; it will display select information about each clinical trial and will provide links to a registry where more information is available. 

Concluding remarks

In an effort to increase public transparency, sponsors are expected to register their clinical trials and provide summary results within the timelines outlined above. This approach aligns with global clinical investigation transparency initiatives aimed at making clinical investigational data, including results, publicly available. 

As noted in the guidance, HC may propose regulations for clinical trial registration and reporting summary results in the future.

For additional information, refer to: 

• Guidance on the registration of clinical trials and public disclosure of results
• Canada’s search portal for clinical trials
• Applications for medical device investigational testing authorizations guidance document