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Before any new medicine or medical device is placed on the market, it must be tested through clinical trials. Clinical trials are research studies, which require the participation of volunteer children, adults, and families. Results are then reviewed to determine if the drug, practice or medical device should be made available to the public. Clinical trials are a vital part of scientific research that play an important role in the development and evaluation of new medicines, treatments, and cures.
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Once a new drug has been discovered, Phase I clinical trials are conducted by testing the drug on tissue cultures and small animals, and observing any changes that the drug may cause. |
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If the Phase I trials are promising, Phase II clinical trials are conducted by administering the drug to other animals and conducting several laboratory tests. These tests look at how the drug affects immune systems, reproductive systems, and other effects, and also attempts to determine the proper dosage. |
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After Phase I and II clinical trials, a preclinical submission must be filed with the Minister of Health before a new drug will be approved for the next stage of testing. |
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Phase III clinical trials involve approved clinical investigators administering the drug to humans who are well informed of the potential risks and benefits of the study, and are subject to several restrictions and conditions. |
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After successful Phase III clinical trials, a New Drug Submission must be filed with the Minister of Health before the drug will be approved for marketing and sale in Canada. |
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After a drug has been approved for marketing and sale in Canada, monitoring continues throughout the entire period the drug is available. |
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