Cancer Clinical Trials at Mount Sinai:
An overview for patients
The Tisch Cancer Institute offers a wide range of clinical trials for patients with cancer. Our Cancer Clinical Trials Office (CCTO), under the leadership of Medical Director Marshall R. Posner, MD, Associate Medical Director Matthew Galsky, MD and Director of Clinical Research Operations Rosemarie Gagliardi, offers Phase I, II, and III trials.
What is a clinical trial?
Clinical trials are research studies that involve humans. These studies test new ways to prevent, detect, diagnose, or treat diseases. Many standard therapies used in cancer treatment today began as drugs that were tested in clinical trials.
- Phase One clinical trials test a potential drug’s dosing, confirm effectiveness, and look for side effects.
- Phase Two trials compare the new drug, already studied in the phase one trial, to a therapy that is known to be effective (either in addition to the known therapy, or in comparison).
- Phase Three clinical trials continue to test the effectiveness of drugs that have gone through Phase One and Phase Two studies in an even larger group of patients.
For more information on cancer clinical trials, visit the National Cancer Institute (NCI).
Why join a clinical trial?
It is a myth that clinical trials are only for people with “no other options.” Trials provide access to promising new treatments or approaches that are often not available outside the clinical trial setting. The treatment being studied may be more effective than the current standard treatment. Results from the study may help others in the future and are key to moving the field of cancer research forward.
Who can participate in a clinical trial?
Choosing to participate in a clinical trial is an important personal decision – and a voluntary one. Clinical trials are appropriate for different types of people depending on the purpose and phase of the trial. Each clinical trial clearly states who can participate based on the type of cancer or other disease, prior treatments, overall health status, and a number of other factors specific to each trial. Only patients who give informed consent and meet all the eligibility criteria are entered into clinical trials.
It is often helpful to talk to your doctor, family members, or friends about deciding to join a trial. You can also talk to the study research staff and ask questions about specific trials.
How do I find a clinical trial?
Ask your doctor if you may be a candidate for a clinical trial. For a list of currently open cancer clinical trials at the Icahn School of Medicine at Mount Sinai, see Clinical Research and Clinical Trials.
Safety and Oversight
The Tisch Cancer Institute (TCI) has clinical research oversight over all cancer clinical research conducted at Mount Sinai. Cancer-related clinical trials are required to be reviewed by the Protocol Review and Monitoring Committee (PRMC). PRMC-approved trials are then reviewed by Mount Sinai’s Institutional Review Board (IRB). The CCTO works in conjunction with the Office of Research Services to facilitate research through a centralized infrastructure providing resources and expertise. Clinical Research Nurses and Coordinators work with the Physicians to identify and provide recruitment, education, and support of patients on cancer clinical trials.