PHASE ONE is named after the three phases of clinical trials required by the Federal Drug Administration before a new drug or treatment is approved and made publicly available to cancer patients. Each phase takes many years and can cost millions of dollars.
Phase I is the first time a drug is tested on real patients and helps to determine the appropriate dose and schedule of a given drug and its side effects. Patients enrolled usually have advanced cancers which have progressed through standard therapy or for which standard therapy does not exist.
The Phase II trial applies the Phase I information on dose and schedule and tries to get a hint of efficacy. The Phase III trial is the final set of studies and usually involves hundreds, if not thousands of patients worldwide.
Clinical trials are the only way to understand the best and safest therapies available to patients with any disease.