On February 23, 2023, Health Canada posted a draft guidance document for the protocol registration of clinical trials and public disclosure of results, proposed a public search portal. This document provides guidance to sponsors of Health Canada-authorized clinical trials to support the registration and public disclosure of results using international registries that complies with World Health Organization (WHO) standards. Below are some of the key points from the draft guidance:
- A Letter of Authorization is issued for the trials on medical devices, and a Notice of Authorization is issued for trials on natural health products (NHPs), a No Objection Letter (NOL) is issued for clinical trials investigating drugs if all regulatory requirements have been met in the trial application.
- A trial would be “authorized” if the trial received: No Objection Letter or a Letter or Notice of Authorization or a clinical trial authorization for a COVID-19 related drug or medical device.
- Health Canada recommends sponsors to register their Health Canada-authorized clinical trial prospectively (before recruitment of the first participant) in a clinical trial registry that complies with WHO standards. If a Health Canada-authorized study is already registered, sponsors should add all the Canadian sites to their existing registration record before recruitment begins at that site.
- Health Canada recommends sponsors to submit the summary results of their Health Canada-authorized clinical trials within 12 months following primary study completion to the same registry where the clinical trial was registered.
- Summary results information includes 4 areas: Participant flow, Demographics and baseline characteristics, Outcome Measures, and Adverse events. Draft guidance to be referred for the detailed information.
- Health Canada mentioned two widely used registries that are publicly accessible and part of the WHO ICTRP Network which accepts clinical trials conducted in Canada: ISRCTN in the United Kingdom and ClinicalTrials.gov in the United States.
- Not all registries and data providers that comply with WHO international standards will accept clinical trials conducted in Canada.
- Health Canada’s proposed Clinical Trials Portal will display the information of all the authorized Canadian drug trials collected from data sources: Clinical trial applications submitted to Health Canada (after authorization), WHO ICTRP, and registries complying with WHO standards.
- Subsequent releases of the portal under a phased implementation strategy are planned.
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