Canada’s regulatory approach to drugs for rare diseases: find clinical trials

From Health Canada

Find a clinical trial

Health Canada has authorized certain clinical trials in patients in Canada.  Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are:

• ClinicalTrials.gov
• Current Controlled Trials International Standard Randomized Controlled Trials Number Register

Many clinical trials have difficulty recruiting patients in a time- and cost-effective manner.  At the same time many patients and their primary care providers are eager to participate and have difficulty finding available trials. These databases aim to address both these issues.

You can search by the:

• Disease name
• Recruitment status (recruiting, ongoing, completed)
• Selection criteria (to ensure patient suitability)
• Geographic location

Additional search information may include a search based on the:

• drug name
• manufacturer
• trial sponsor

Selection criteria can be cross-referenced to ensure patient suitability.

The international resource Orphanet and its Canadian counterpart Orphanet Canada provide an online portal specific to rare diseases that includes information about:

• clinical trials
• specialized clinics
• medical laboratories
• registries gathered from all over the world

This resource offers a directory of specialized information for:

• people with rare diseases
• health service providers

The suitability of a clinical trial for a patient depends not only on the selection criteria, but on other considerations regarding the study, including expected risks and benefits for the participating patient. To further support patient care, if appropriate, in some cases sponsors offer extended access to patients who do not meet the selection criteria for an ongoing clinical trial. In addition physicians may propose other avenues to access, such as:

• hosting an additional trial site to an ongoing clinical trial
• offering to oversee a trial which is specific to the patient
• requesting access through Health Canada’s Special Access Programme using a Special Access Request (SAR) Form