This winter, new draft Health Canada guidelines for clinical trial registration and results posting will be released. At a time when industry-wide transparency efforts are increasingly focused on initiatives that promote sharing anonymized documents and datasets, it is refreshing to see we are not losing sight of the important role trial registries play in the patient care landscape.
Health Canada’s direction and the approach to implementing these guidelines for clinical trial registration and results posting is a prudent one, for a few reasons:
They’re not trying to reinvent the wheel.
Instead of building yet another time-consuming registry, the proposed Health Canada guidelines for clinical trial registration and results posting will be able to be satisfied by registering trials and posting result summaries to ClinicalTrials.gov, ICRTP, or any of the other WHO Primary Registries already in existence.
They align with existing international standards for timing.
Health Canada will require clinical trial result summaries be posted to one of the aforementioned registries within 12 months of study completion, similar to current requirements in the U.S. and Europe.
They’re making data accessibility a priority.
A new search portal on the Health Canada website will allow clinicians, potential trial participants, and the general public to search across multiple data sources (i.e. ClinicalTrials.gov and ICRTP) for information about any trials approved in Canada, in a seamless and user-friendly way.
The importance of information accessibility cannot be overstated. Clinicians require a quick and reliable way to find information about trials for which their patients are eligible.
Patients, in turn, need to be able to find and (importantly) understand the details of the trial and investigational interventions. By arming patients with better health literacy, they can then have an informed conversation with their physician about the best course of action and whether a particular trial is a good fit.
While there remains much room for improvement in facilitating better health literacy, registries serve an important role in providing actionable information about the available options to those who need it.
Do you have questions about the upcoming Health Canada guidelines for clinical trial registration and results posting? If so, email us at email@example.com