On April 26, 2013, Health Canada published a notice to inform clinical trial sponsors that information about Clinical Trial Applications (“CTAs”) will be published.
The publication of information applies to authorized CTAs that were issued a No-Objection Letter after April 1, 2013. The following information about the clinical trial will be published in Health Canada’s clinical trial database:
- Protocol number;
- Protocol title;
- Drug name;
- Medical condition;
- Study population;
- Authorization date;
- Sponsor name;
- Health Canada control number; and
- Start and end date of the clinical trial.
Health Canada’s clinical trials database makes clinical trial application information publicly available through Health Canada’s website. The database is publicly accessible and will serve as a central index of information that will include information on phase I, II and II drug and biologics clinical trials. The database will not include medical devices or natural health products when it is launched.
The clinical trials database will be implemented by Health Canada in May 2013.
Going forward, sponsors may wish to amend their clinical trial application and informed consent templates to include reference to the Health Canada database. This initiative is yet another measure to increase transparency within Health Canada’s regulatory process. Increasing accessibility to clinical trial information may improve efficiency in research. Moreover, the increased public knowledge of on-going clinical trials in Canada may increase study subject engagement and recruitment in clinical trials.
Link to Health Canada’s website: