Phases of Clinical Trials

Before a drug is approved for use, it goes through various stages of development and testing. A cancer drug is initially discovered in the laboratory. It is then tested on laboratory animals and specific cancer cell lines. Once it appears that a particular drug may be effective in inhibiting cancer growth, it enters the clinical phases of development.

Phase I: the first step is determining if a newly discovered drug is safe for patient use. It is during this phase that it is determined how the drug would be best administered, whether there are any harmful side effects, and the safest dose to use.

Phase II: doctors test to find the effectiveness of the new drug on specific cancers and whether the new drug would improve on the present available treatments, the ultimate goal.

Phase III: with the effectiveness and safety of the new drug having been determined, doctors will then compare the new treatment to the standard treatment. This is accomplished through a randomized study. A study includes two separate groups:

• The Intervention Group – those who are given the new treatment
• The Control Group – this group will receive either the standard treatment or a placebo (a treatment that contains no active ingredients)

Phase IV: the post-marketing phase of a trial. After the drug is approved by the FDA and is available on the market, it can be further studied for better ways of administering it. Other clinical research studies address the management of chemotherapy-induced side effects and cancer symptoms that continue to be inadequately treated in cancer patients, with significant impact on quality of life.