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Questions About Clinical Trials

How do clinical trials work?


Richard Moore, M.D., runs several clinical trials for women with ovarian cancer and other cancers of the reproductive tract.

After basic science researchers have studied a potential new treatment in a laboratory and often in animal models, the treatment advances into early-phase clinical studies.

Phase 1 and 2 trials are designed to evaluate the safety, side effects, and the proper dose of the drug being tested. Phase 1 studies involve a small number of patients. Phase 2 studies enroll more people, and start to look at treatment benefits. Some newer, phase 1 and 2 trials also enroll patients based on the unique molecular characteristics of their tumors, to test therapies that target those molecular mutations.

Phase 3 trials are larger, often involving hundreds or thousands of patients, and are usually seeking to confirm a new treatment’s effectiveness by comparing it directly to the current, standard care.

Clinical trials are designed to measure certain outcomes, including: response rates (such as whether a tumor shrinks or stabilizes); progression-free survival (the time interval between the start of the trial and when cancer returns or grows); overall survival (the time until death); quality of life (activity level and cognitive function, for example) and side effects (neuropathy, fatigue, etc.).

Who is in charge of my care?

Doctors and scientists who conduct clinical trials are called “principal investigators.” They are seeking to discover risks and benefits of new treatments.  Nurses and clinical trial coordinators also work closely with doctors to implement the best care possible during clinical studies.

Will I receive a placebo (a sugar pill)?

Some patients are concerned about receiving a placebo in a clinical trial because a placebo amounts to no treatment at all. The vast majority of cancer trials do not use a placebo. If a trial does include an arm with an inactive treatment, it is used when there is no standard treatment and done with the consent of the patient.

clinical trials fusion area photoWhat about the costs of clinical trials?

Most patients don’t incur additional costs to participate in trials but it’s best to talk about your financial concerns with your medical team. Typically, the trial provides the drug/therapy and the oncologist bills a patient’s health insurance for office visits, blood tests, and other forms of standard care. Clinical trials do, however, often require more time by the patients for blood draws, scans, or evaluations. Ask about how your treatment will be administered, and how long it will take. The Wilmot Cancer Center has a special chemotherapy infusion area for many of our clinical trial participants.

The National Cancer Institute recommends that all cancer patients ask their doctors about clinical trials, and to come to a visit with a list of questions: