Home/About Us
Q&As
Other Resources
How You Can Help
News/Articles
Print Documents
Contact Us
|
Types of Trials ~ Current Breast Care Trials at Hartford Hospital
Before a treatment is used, as a standard of care for patients, it is carefully studied. New drugs are studied in the laboratory before they are developed into research trials for patients. There are four different types of research trials: Phase I, Phase II, Phase III, and Phase IV. Phase I clinical trials are performed as a first step in testing a new drug in human beings. Phase I trials are designed to determine the best way to deliver a drug (by mouth or by injection, for example) and to test the safety and the side effects of a new drug. Phase II clinical trials determine if a new drug is safe and effective in the patient population with the disease or condition to be treated. Phase III clinical trials compare a standard treatment to a new treatment in the patient population it is intended to treat. Phase III can be done by a process called “randomization.” Randomization means that the patient does not choose the treatment, but a computer program randomly assigns a patient to a treatment group, which is sort of like flipping a coin. Phase III trials may compare an existing treatment to a new treatment, or a new drug to a placebo, or inactive substance. Some phase III trials are “blinded” which means that neither the physician nor the patient knows which therapy the patient is receiving. A Phase IV trial is conducted after a drug or treatment is approved to evaluate for additional information about the medication, such as length of treatment or medication interaction.