What is a Phase III trial?
Before the FDA will approve a drug, the sponsoring company must conduct several clinical studies. The studies are done in phases to determine what the side effects of the drug are and how effective it is in treating the disease. The earliest studies (pre-clinical, meaning in the lab before they are given to anyone) are to determine if the drug works in the way it was thought to work. Pre-clinical toxicology will look at the safety of the drug before it is given to anyone. Phase I trials evaluate the safety of the new therapy in a small number of human subjects. Phase II trials investigate the new therapy’s safety in a larger group of humans, and determine the most effective dose and duration. Phase III trials are the last part of the clinical development process. In these studies, a large number of patients are treated with the dose regimen that was identified in the earlier trials in order to prove that the new medication is both safe and effective for its intended therapy. When the c
