The majority of studies conducted at Sentara Cardiovascular Research Institute are considered Phase III trials, however, the Institute also participates in Phase II and Phase IV trials, and does a significant amount of device studies, as well as original research by our own Sentara physicians.
During Phase III studies, the experimental study drug or treatment is given to large groups of people (approximately 1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. Because these are large-scale tests with hundreds or thousands of participants nationally and/or international, they are most often the clinical trials that make news headlines. They are the culmination of earlier phase I and phase II trials that include many fewer people and still earlier pre-clinical experiments with animals. They are also the final tests in humans before the FDA is asked to authorize sale of new medicines.