By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have begun making some information on medical device clinical trials available upon request in an effort to boost public access to such data.
Health Canada’s new policy entails sharing information including:
- Protocol title
- Device name
- Medical condition
- Study population
- Authorization date
- Study end-date
- Name of manufacturer or importer
Regulators will not, however, provide testing information pertaining to healthy volunteers. Manufacturers and importers will handle questions regarding patient enrollment criteria, testing sites and investigation status.
Expect to see more medical device market regulators pursue similar initiatives for more transparent clinical trial information going forward.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.