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Clinical Trials

Clinical Trials

What are clinical trials?

Clinical trials are prospective biomedical or behavioural research studies on human participants designed to answer specific questions about biomedical or behavioural interventions, including new treatments and known interventions that warrant further study and comparison.

Pre-clinical studies:

When researchers develop new drugs, the first tests are called pre-clinical

studies. These tests are done using cells, tissue samples or animals. If the

pre-clinical test results are promising, the next step is a clinical trial.


Clinical trials:

Clinical trials are studies to find out whether a drug is safe and effective

for people. The people who take part in trials are volunteers.

They may be:

  • Healthy people who want to help move medical knowledge forward

  • Patients with a disease



The person or organization that tests a drug is called a sponsor.

Health Canada does not sponsor or conduct drug research. Sponsors of

clinical trials are usually:

  • Drug companies

  • Researchers from a hospital, university or research organization


Clinical trial application

Before conducting a trial, the sponsor submits a clinical trial application to Health Canada. Our scientists review the application to make sure:

  • Drugs are used in the right way for the patients being studied

  • Any risks in using the drug are lowered as much as possible

  • The best interests of the people taking part in the trial have been considered

  • Goals of the trial can be met


Clinical trials in Canada must follow Division 5 of the Food and Drugs Regulations and good clinical practices. They must:

  • Protect the health of the people in the trial

  • Be well designed and conducted by trained professionals

  • Be monitored and side effects reported

  • Be reviewed by a Research Ethics Board

About Clinical Trials for Drugs

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Four Phases of Clinical Trials

  • Phase 1: These trials test an experimental drug on a small group of people for the first time. The purpose is to:

    • Look at the drug's safety

    • Find out the safe dosage range

    • See if there are any side effects

  • Phase 2: The drug is given to a larger group of people (usually 100 or more) to:

    • Gather data on how well the drug works to treat a disease or condition

    • Check the drug's safety on a wider range of people

    • Figure out the best dose

  • Phase 3: The drug is given to even larger groups of people (usually 1,000 or more) to:

    • Make sure it is still effective

    • Monitor side effects

    • Compare it to commonly used treatments

    • Collect information about the drug that will allow it to be used safely on the market

  • Phase 4: These trials take place after the drug is approved and is on the market. Information is gathered on things like the best way to use a drug and the long-term benefits and risks.

Possible Benefits

When you take part in a clinical trial, you help others by moving medical research forward. Also, if you have a disease, there could be personal benefits, such as:

  • You may get early access to a new treatment with positive results

  • The treatment may cure or control your condition or improve your quality of life

  • You may get more expert health care from the research teams that are involved in the study

Interested in learning more about clinical trials? Click here

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