Clinical Trials in Canada

What is a clinical trial?

Clinical trials are research studies conducted with human participants to test the safety and effectiveness of medical interventions, such as drugs and medical devices. They are also used to verify the pharmacological effects of drugs and identify any adverse effects. In Canada, natural health products also need to undergo the clinical trial process.

Clinical trial process

Health Canada is responsible for monitoring clinical trials; it does not conduct trials. Approximately 900 clinical trials are approved each year. Clinical trials are sponsored by individual pharmaceutical companies or university or hospital researchers.

The sponsor of a clinical trial must submit a clinical trial application to Health Canada. The application is reviewed by Health Canada scientists to ensure the following:

• Medications are being used the right way for the individuals in the study.
• The risks of using the drug are as low as possible.
• The best interest of the people in the trial have been considered.
• The goals of the trial can be met.

Clinical trials in Canada must follow the Division 5 of the Food and Drug Regulations, which provides specific rules and steps a sponsor must follow for a clinical trial. Sponsors must also follow good clinical practices, including the following:

• The trial must protect the health of trial participants.
• The trial must be well-designed and be conducted by trained professionals.
• The trial must be monitored, and side effects must be reported.
• The trial must be reviewed by a Research Ethics Board.

When a drug trial is completed, the sponsor can then apply to Health Canada for market approval for a new medication. This application must contain detailed information, including the following:

• The results of pre-clinical studies and clinical trials
• Details about how the drug is made, packaged and labelled
• Health claims and information about any side effects

Health Canada may approve the drug for the market if the benefits are greater than the risks or the risks can be lowered. Once approved, the new medication will get a Notice of Compliance (NOC) and a Drug Identification Number (DIN).

Health Canada clinical trial database

Health Canada’s clinical trial database is a source of information for Canadian clinical trials (phase 1 through phase 3) of pharmaceutical and biological drugs involving human participants. The database is available to the public. It is not a registry, so it does not contain comprehensive information regarding each trial.

The database is not designed to be used for trial recruitment. Furthermore, the database does not contain the following types of trials:

• Clinical trials in healthy volunteers
• Clinical trials of medical devices or natural health products
• Phase 4 trials

As sponsors are not required to inform Health Canada when a trial is complete, information in the database may not always be up-to-date. Health Canada recommends that any questions about a trial listed on the database be directed to the sponsor.