What at the differnet phases of clinical trials?
Phase I Trials: In these studies, a drug is given to small groups of healthy people (typically 20 to 80) for the very first time to determine and establish safety and tolerance of the drug in humans. Phase II Trials: The drug is given to larger groups (typically 100 to 200 volunteers) with the disease/condition to further define and determine an appropriate range of doses and learn more about drug safety and drug effectiveness. Phase III Trials: The drug is now given to larger groups (hundreds to thousands) of people to establish efficacy and expand what is known about the drug’s safety with a selected dose in a broader subject sample. Phase IV Trials: Studies done after a drug is approved. This is a very large group (typically thousands) of subjects – larger than Phases 1-3 – to continue to monitor safety in larger populations. What is a clinical trial? Drugs and medical devices must be proven safe and effective in people before the U.S. Food and Drug Administration (FDA) will approve
