What are Clinical Trials?

Clinical trials are carefully controlled studies that are used to determine the safety and efficiency of new drugs, treatments or medical products are safe and effective. They can be funded through pharmaceutical companies, or other funding sources. All drugs in the U.S. undergo three phases of clinical trials before being approved for general use. Once a drug is approved and used by the general public, a phase 4 study examines possible long-term effects.

The doctors who conduct a clinical trial follow a carefully designed treatment plan called a protocol. This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease. This way, the treatment groups are alike and the results from each can validly be compared.

PHASE I PHASE II PHASE III PHASE IV
Drugs are tested in a few volunteers (20-100) to evaluate safety, determine safe dosage levels, and identify side effects. Drugs have passed phase I & are tested in more people (100-500) to further evaluate safety and effectiveness. Drugs are tested in a large number of people (1000-5000) to confirm long term effectiveness, monitor side effects & compare with commonly used treatment. Performed after a drug has been marketed, to collect information about its effects in various populations, including possible long term side effects.

ALL MEDICATIONS THAT YOU BUY TODAY HAVE BEED TESTED BY THESE METHODS.