The phases of cancer clinical trials

Clinical trials are often divided into phases.  These actually refer to phases in the process of developing a new drug.  Here is the scoop:

·        Phase I studies are small, and their goal is to determine the optimal dose of a drug, or combination of drugs, that can be given safely. This does not mean entirely free of side effects, just an acceptable or manageable level of side effects.

·        Phase II studies are also relatively small and may involve anywhere between 30 and several hundred patients. They are the first studies designed to test how effective a new treatment is against cancer.

·        Phase III studies are large and may involve thousands of participants. They compare the most promising new treatments to the current standard.

·        Phase IV studies usually collect more safety and effectiveness information on new therapies after the U.S. Food and Drug Administration has approved them.



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(c) 2012 Tom Beer and Larry Axmaker