A clinical trial is designed to determine if a new drug or treatment will work on a disease or will potentially be of benefit to the patient. Trials allow doctors and researchers to gain information on the benefits, side effects, and possible applications of a new drug as well as different combinations, doses and new indications of existing drugs. The medical community may be able to determine new ways to detect, diagnose, avoid, and control clinical factors responsible for diseases.
Clinical trials have four research phases.
A Phase I study is the first use of a new drug in humans. It is used to test for safety and side effects, and to determine how the drug should be given. Only a limited number of patients are accepted for participation in Phase I trials. If the Phase I shows safety and mostly positive results, a Phase II trial is initiated to investigate the ideal dosing range of the drug. The therapy is tested in a larger number of patients to determine how well it works, and other possible side effects.