Clinical trials are scientific studies in which new treatments – drugs, diagnostic procedures, and other therapies – are tested in patients to determine if they are safe and effective.
Such trials help scientists answer questions about new cancer therapies, including: what diseases should they be used for? What doses of new drugs are most effective? And which patients can benefit the most from them?
Nearly all cancer drugs in use today were tested and made available to patients through clinical trials.
Search current cancer-related clinical trials offered through Dana-Farber and other Dana-Farber/Harvard Cancer Center member institutions.
Search a registry of federally and privately supported clinical trials conducted in the United States and around the world.
If you’ve never been part of a clinical trial before, you may have concerns and questions about what to expect.
In this video, patients and clinicians explain what clinical trials are and offer suggestions to help patients decide whether or not to enroll in a study. You can also order this video on DVD.
This video is not intended to be a substitute for discussion between you and your physician. If you are considering enrollment in a clinical trial, please talk to your clinical trial study team before making your decision.
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.
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