What are the four phases of a clinical trial?
• Phase I Trials – Are purely safety studies. These trials are designed to determine the safety, tolerability, best dose and side effect profile of a new drug. These studies usually have small numbers (less than 100) of patients enrolled in them. • Phase II Trials – Are similar to phase I trials, but study a larger number of patients usually in the number of 150-300, depending on the drug and population of patients being investigated. • Phase III Trials – Are usually called ‘pivotal studies’ since these are larger trials, many times involving thousands of patients to establish not only safety in a larger population of subjects, but to also determine the efficacy of a drug or therapy and or compare to an existing therapy on the market. • Phase IV Trials – Are clinical trials conducted after the FDA has granted approval for a new drug, device or new therapy and is available to the general public. This aspect of drug development is done to further assess the safety of a drug after it is b
