It's Your Health
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
Every year, Health Canada receives hundreds of new clinical trial applications for testing new drugs or new uses of approved drugs on humans. These trials give Canadians a chance to take part in research that could improve their health. Clinical trials can be an important treatment option, but like all drugs, the ones used in clinical trials have potential benefits as well as risks because there is usually limited information about the safety and efficacy
of the drug being studied.
Before you take part in a clinical trial, you should discuss the potential risks and benefits with your health care provider, so that you can make an informed decision about your health and participation in a study.
The basics on clinical trials involving drugs
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 results are promising, the next step is a clinical trial.
Clinical trials are studies to find out whether the drug is safe and effective for people. The people who take part in trials are volunteers. They may be patients with a specific disease, or healthy people wanting to contribute to the advancement of medical knowledge.
The individual or organization that wants to test the drug is called the sponsor. Health Canada does not sponsor or conduct drug research. Clinical trial sponsors are usually drug companies, or researchers from a hospital, university, or research organization.
Before conducting a trial, the sponsor submits a clinical trial application to Health Canada. Our scientists review the application to make sure:
- the use of the drug in the patients being studied is appropriate
- any risk associated with use of the drug is minimized as much as possible
- the best interests of the people participating in the trial are upheld
- the objectives of the trial are likely to be achieved
Clinical trials in Canada are done under strict conditions defined in Canadian Regulations and must follow Good Clinical Practices. The regulatory framework was put in place to:
- protect the health of the people in the trial
- make sure the trials are well-designed and conducted properly by trained professionals
- make sure that trials are monitored adequately and potential side effects are reported to Health Canada
- require that trials are reviewed by a Research Ethics Board
The people who carry out clinical trials are called investigators. Canadian law requires that investigators are physicians or dentists. Other staff that could be involved in a clinical trial includes researchers, nurses, or other health professionals. Most often, the trials have research teams and take place in hospitals, medical clinics, doctors' offices, and universities.
The four phases of clinical trials
Clinical trials are done in phases. Each phase has a different purpose and helps researchers answer specific questions.
- Phase I - These trials test an experimental drug on a small group of people for the first time. The purpose is to:
- assess the drug's safety
- find out what a safe range would be for dosage
- identify side effects
- Phase II - The drug is given to a larger group of people (usually 100 or more) to:
- obtain preliminary data on the effectiveness of the drug for a particular disease or condition
- further assess the drug's safety
- determine the best dose
- Phase III - The drug is given to even larger groups of people (usually 1,000 or more) to:
- confirm its effectiveness
- monitor side effects
- compare it to commonly used treatments
- collect information that will allow the drug to be used safely on the market
- Phase IV - These trials are done after the drug is approved and is on the market. They gather information on things like the best way to use a drug, and the long-term benefits and risks.
- http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/clinical_trials-essais_cliniques-eng.php?utm_source=Facebook_HC&utm_medium=social&utm_content=july15_clinical+trial&utm_campaign=social_media_13
Written by Unknown
OpenDoor aims to provide Health Awareness. l OpenDoor is a platform used to Learn and Coach.
0 comments:
Post a Comment