How Are Clinical Trials Categorized?
Clinical trials are categorized as Phase III, II or I. Classification depends on the purpose of the study and determines the total number of patients who may receive treatment on that clinical trial. Newly-diagnosed patients are often treated using a Phase III trial. Phase III studies compare the new treatment to a standard (current, state-of-the-art) treatment. At the beginning of the study, doctors don’t know if the new treatment is better than the standard treatment. Phase III trials typically enroll hundreds to thousands of patients, and are carried out in treatment centers nationwide. If a drug successfully completes the Phase III level of testing, the pharmaceutical company that makes it can apply for FDA approval for this use. In cases when the standard of care or Phase III treatment is not effective, your child’s healthcare team may recommend a Phase II trial. Phase II studies investigate whether the new treatment works for a specific type of cancer. They also continue to evalu
