Health Canada's Clinical Trials Database Frequently Asked Questions
What is Health Canada's Clinical Trials Database?
Health Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs.
What information can I find on the database?
A clinical trial that is found in the database indicates that it has met Health Canada's requirements. The database may also assist Canadians in finding clinical trials that might be relevant to their medical condition.
What information is NOT available on the database?
The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. It is not intended to promote or recruit for specific clinical trials and therefore does not contain contact information of clinical trial sponsors.
How do I get the contact information of the sponsor?
We suggest that information on the sponsor be obtained through a web search using common internet search engines. Health Canada does not provide the coordinates of the sponsor.
What do I need to do if I am interested in participating in a clinical trial?
Speak to your doctor and contact the sponsor of the trial for additional information, including whether the trial is still recruiting and the location of clinical trial sites across the country.
Information about the various trials sponsors are conducting may also be available on the sponsors' websites.
What is a clinical trial "sponsor" and who conducts clinical trials?
A clinical trial sponsor is an individual, corporate body, institution or organization that conducts a clinical trial. The sponsor is responsible for every aspect of a clinical trial, including ensuring that the trial is carried out under good clinical practices at each clinical trial site.
Each clinical trial site must have a Qualified Investigator, i.e., a licensed physician or dentist. The Qualified Investigator is the person responsible to the sponsor for the conduct of the clinical trial at the clinical trial site.
Will Health Canada disclose additional information other than what is available in the database?
Health Canada is providing only the information in the database, and will not make additional information available at this time. For any other information, patients should speak with their physician, and the clinical trial sponsor should be contacted directly.
Health Canada encourages sponsors to register their clinical trials in available registries. Therefore, additional information on clinical trials may be available in clinical trial registries such as Clinicaltrials.gov, International Standard Randomised Controlled Trial Number Register, and European Union Clinical Trials Register. These and other registries can also be accessed through the search portal provided by the World Health Organization. Finally, a Canadian registry focused on clinical trials in cancer may also be consulted, Canadian Cancer Trials.
What does the information found under Trial Status in the database mean?
A "PENDING" status means Health Canada is pending the receipt of information from the sponsor indicating that the trial started. An "ONGOING" status means Health Canada has received information from the sponsors indicating the proposed study start date, and an "ENDED" status means Health Canada has received information from the sponsors indicating that the clinical trial has ended. It should be noted however, that clinical trial sponsors are not required to inform Health Canada when a trial is completed. Therefore, it is possible that trials that appear to be ongoing may actually be completed. Sponsors should be contacted for the most up-to-date and accurate information about the status of a clinical trial.
Why is it that the trial I am participating in cannot be found in the database?
The Clinical Trials Database contains only information on phase I, II, and III clinical trials conducted in patients. Trials conducted in healthy volunteers, and trials with natural health products and medical devices are not included in this database at this time.
Also, Health Canada does not authorize Phase IV trials, i.e., trials for which a marketed drug is used according to its approved conditions of use. The Phase IV trials don't need to be reviewed by Health Canada, and therefore, information about these trials is not included in the database.
It is important to note also that this database is prospective and that only information on clinical trials authorized after April 1, 2013 will be available from the database.
I have questions about a clinical trial I'm participating in. Who should I contact?
If you have questions about a clinical trial you are participating in, you should discuss them with the study physician. You may also communicate with the Research Ethics Board that approved the clinical trial. The contact information for the Research Ethics Board should be found on the Informed Consent Form that was provided to you before you enrolled in the trial.
What is Health Canada's role in regulating clinical trials?
Health Canada is responsible for reviewing and authorizing the importation or sale of drugs for human clinical trials in Canada. Sponsors of phase I, II, and III clinical trials are required to file a clinical trial application (CTA) for Health Canada to review.
Health Canada reviews the application and decides to accept or reject the application. Trials would be rejected if the use of the drug for the purposes of the clinical trial will endanger the health of a clinical trial subject or if the trial is not in the best interests of clinical trial subjects, or if the trial is not expected to meet its objectives.
Health Canada will authorize the use of the drug in the clinical trial if it meets safety requirements and is expected to meet its objectives. It is important to note that in addition to Health Canada's authorization, a Research Ethics Board also needs to review and approve the trial before the latter is initiated. After clinical trials are ongoing, Health Canada monitors the emerging safety data by assessing serious unexpected adverse drug reactions and other information filed by the sponsor. Health Canada may also carry out clinical trial site inspections to verify if the conduct of a trial meets the requirements of good clinical practices as stipulated in the Regulations.
I'm concerned about the conduct of a clinical trial. Who should I contact?
Clinical trials in Canada are required to be conducted under good clinical practices (GCP). GCP includes review and approval of the trial protocol by a Research Ethics Board, and appropriate Informed Consent of clinical trial subjects. Prospective clinical trial subjects should be given the opportunity to read the Informed Consent Form, ask any questions about the clinical trial, take the consent form home to think about the trial, and discuss it with their family and friends, if they wish to do so, prior to enrolling in a clinical trial. If you have concerns about how a clinical trial is being carried out, you may contact the Research Ethics Board that approved the clinical trial (contact information should be found on the Informed Consent Form), or contact Health Canada by email at GCP_BPC@hc-sc.gc.ca or by phone at 1-800-267-9675.
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