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To qualify for a particular study, participants must meet a carefully defined set of criteria. These usually relate to age and gender, cancer type and stage, and the types of treatments they have already received.
Before agreeing to participate, patients learn about possible risks and benefits of the therapy being studied. As the trial progresses, participants are given new information that may affect their willingness to stay in the trial. Participants may withdraw from the trial at any time.
Before any clinical trial begins, it must be approved by its host institution's Institutional Review Board (IRB), which includes researchers and physicians. The IRB considers whether proposed studies are safe and well planned and whether they will ultimately
advance patient care. It also reviews studies to ensure patients are adequately informed about the risks of participating in clinical research. In all studies, the health of each patient is closely monitored during the course of the trial.
Cancer clinical trials are divided into three distinct stages. Only when the third stage has been successfully completed, and the Food and Drug Administration has given its approval, can a new treatment become part of standard therapy.
Phase I trials are designed to determine the safety of a new cancer therapy. They evaluate how a new medication should be given (orally, intravenously, or by injection), how often, and at what dosage, but are not designed to test if a new therapy is effective. Phase I trials generally enroll only a small number of patients.
Learn about Phase I clinical trials at Dana-Farber's Early Drug Development Center (EDDC)
Phase II trials provide information about how well a new medication works and generate more information about patient safety. Phase II studies usually focus on a specific type of cancer.
Phase III trials compare new treatments with standard ones to determine which is safer and more effective. Phase III trials generally involve a large number of participants and often take place at several health centers at the same time. Patients are randomly assigned to receive either the new cancer therapy or a standard one.
See our Insight blog for information and inspiration about Dana-Farber's clinical trials.
Clinical Trials Questions?