Clinical trials are the rigorous, scientific study of new therapies or procedures. It represents a carefully controlled process by which the patient's rights and well-being are always paramount while trying to make available new, promising therapies. All the “miracle drugs” of the last decade (such as Gleevec®, Rituxan®, and Herceptin®) have gone through the clinical trial process.

PHASE I
A Phase I trial is the first study of a new agent in humans; the drug has gone through exhaustive tests in cell lines and animals, and indicates promises for efficacy.

PHASE II
Phase II trials utilize the information gained from Phase I testing, the safest and potentially most effective dose and its schedule. The new agent is then applied to selected groups of patients.

PHASE III
Phase III trials determine whether a new therapy is of value in comparison to the standard of care or whether it is safer or better tolerated. These are often very large studies

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