involves greater numbers of patients than in phase II, aimed at gaining additional data about effectiveness and safety needed to evaluate the benefits and risks of the drug. Results yield data that will provide information that eventually will go on physician labeling.
A larger number of patients (several thousand) take part in this phase. It is generally conducted simultaneously at multiple test centers in a variety of countries. Additional parameters such as rare undesirable side effects, allergies, sensitization, etc. are carefully noted, since when phase III of the clinical trial is concluded, the application for approval is made.
The third and last round of testing before application for market of a drug is conducted on large populations of affected patients. These studies usually compare the new drug with standard therapy for the relevant disease. Phase III trials usually provide the information included in the drug's package insert and labeling.
The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
the third and final clinical trial of an experimental drug. This third stage in a new drug's approval process expandes the test to several thousand volunteers. The purpose is to evaluate the drug in a larger population to make sure the results of the first two phases hold true in a larger base. Problems involving drug interactions commonly surface during this third stage. Phase II clinical trials are part of the U.S. FDA approval process.
The treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.