Clinical trials are research studies conducted to determine whether a medical strategy, treatment or device is safe and effective for use in humans. Trials are experiments in which novel drugs or treatments are tested in people, sometimes for the very first time. Clinical trials are very different from routine medical care (including prescribed use of FDA-approved drugs), because doctors and researchers don’t know exactly how the treatment or device will affect people.
Some clinical studies are not used to test a treatment or device but instead aim to observe patients in order to better understand a disease. These “observational” studies may be used to determine how to detect or diagnose a disease, or to optimize testing procedures for future trials.