Clinical Trials
Clinical Research trials are done to determine the safety and effectiveness of a new drug or procedure in people. During this process, the treatment goes through “phases,” beginning with the first use in people through approval for general use by the Federal Drug Administration (FDA).
Is the treatment safe?
After an experimental drug or treatment has been tested in the lab and/or on animals, it enters a phase 1 trial. These trials involve a small number of patients to test safety in humans and determine the correct dose of a drug. These trials also help determine the best way to give the drug, whether oral or intravenously.
Does the treatment work?
After determining that a treatment is reasonably safe in people, it enters phase 2 trials. These are done to test for effectiveness – does the treatment work? Since a larger number of people are studied, further information is gained on safety during phase 2 trials.
Does the new treatment work better than the standard treatment?
Phase 3 trials test the new drug or treatment on hundreds or thousands of individuals. These studies are often “double-blind” trials, which mean that neither the patient nor the investigator knows which treatment is being used. They are designed to answer the question of whether, or not the new treatment works better, or has fewer side effects than the standard treatment.
Is the treatment safe over time?
Phase 4 trials are less common and serve to answer questions after the FDA has already approved a drug for general use. These can address questions such as long-term safety of a drug, or other circumstances in which the drug may be helpful.
