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Clinical research |
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CopyRight@IICRM, 2008 Developed by Mica Technologies.. |
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What is Clinical Trial ?
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. What are the phases of clinical trials?
Four Phases of Clinical Trial
Phase I Trials Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II trials The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III trials The study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV trials Post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
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