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  2. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study ...

  3. Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and ...

  4. Clinical trials of drugs and medical devices advance through several phases to test safety, determine effectiveness, and identify any side effects. The FDA typically requires Phase 1, 2, and 3 trials to be conducted to determine if the drug or device can be approved for further use.

  5. May 8, 2023 · Clinical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and...

    • On This Page
    • The Issue
    • About Clinical Trials For Drugs
    • Phases of Clinical Trials
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    • The Role of Clinical Trials in Drug Approvals
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    Every year, Health Canada receives hundreds of new clinical trial applications. These applications are to test new drugs (including vaccines) or new uses of approved drugs on humans. When you participate in these trials, you have a chance to take part in research that could improve your health or the health of others. Clinical trials can be an impo...

    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: 1. patients with a disease 2. healthy people who want to help move medical knowledge forward

    Sponsors

    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: 1. drug companies 2. researchers from a hospital, university or research organization

    Clinical trials are often done in 4 phases. Each phase has a different purpose and helps researchers answer specific questions. Some trials combine phases. 1. Phase 1: These trials test an experimental drug on a small group of people for the first time. The purpose is to: 1.1. look at the drug's safety 1.2. find out the safe dosage range 1.3. see i...

    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: 1. you may get early access to a new treatment with positive results 2. the treatment may cure or control your condition or improve your quality of life 3. you may get more expert health...

    If your reason for being in a clinical trial is to get a new treatment, be aware that this may not happen. Clinical trials often compare a new drug to: 1. an approved drug that is already on the market 2. a placebo (a dummy treatment with no active ingredients) In many cases, people are not told which treatment they are getting. This is done to mak...

    If you participate in a clinical trial, you should understand what is involved and give your consent before starting the trial. Read the informed consent formbefore you decide. By understanding the benefits and the risks, you can make an informed choice about participating. It's also a good idea to talk to your family and friends. If you have quest...

    Pre-market stage

    The pre-market stage consists of: 1. pre-clinical studies 2. clinical trials 3. regulatory product submission 4. submission review 5. market authorization decision If clinical trials prove the drug's benefits are greater than its risks, the drug company will apply to Health Canada for market approvalto market that drug. This application includes detailed information about the drug's safety, efficacy and quality. This information includes: 1. the results of pre-clinical studies and clinical tr...

    Post-market stage

    The post-market stage involves the surveillance, inspection and investigation of a drug while it is on the market.

    Ensuring safe and effective drugs

    Health Canada plays an active role in making sure Canadians can get safe and effective drugs. As part of this work, we protect the health of Canadians who take part in clinical trials. We: 1. review clinical trial applications 2. make sure that drug companies lower the risk of side effects by doing all of the safety tests 3. keep track of negative side effects that can happen in clinical trials and take action when needed In some cases, inspectors visit sites where clinical trials take place...

  6. What is a clinical trial? Clinical trials look at new ways to prevent, detect, or treat disease. The goal of clinical trials is to determine if a new test or treatment works and is safe. The idea for a clinical trial —also known as a clinical research study —often originates in the laboratory.

  7. Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people. Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate.

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