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| Each phase of a clinical trial has a different purpose and helps scientists answer different questions. |
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental 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.
In Phase II trials, the experimental 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.
In Phase III trials, the experimental 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 experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
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More Information:
Source:
U.S. National Institutes of Health
April 4, 2010
Reviewed by
Dr. Boaz Ancselovic, MD, Geriatrician, Alzheimer's Weekly.
Edited by Peter Berger, Alzheimer's Weekly.
COPYRIGHT © 2010 Alzheimer's Weekly LLC.
All Rights Reserved.
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