What is a clinical trial?
Clinical trials are studies that directly involve volunteer patients.
They stem from a need to identify better treatments. They are the most responsible, coordinated way to evaluate the safety, effectiveness, dose, and outcomes for new therapies. Many of today’s standard cancer treatments were developed in research labs and then proven to be effective in carefully planned clinical trials.
By voluntarily enrolling in a trial, a patient agrees to receive a certain drug or medical device, or physical or behavioral therapy (a diet or exercise routine, for example). Some trials also test ways to prevent cancer, or to manage side effects. Depending on the design of the trial, it’s possible that a patient would randomly be assigned to be in a “control group” and simply receive standard therapy.
There is no way to know in advance if a person will benefit from a clinical trial, but each patient is closely monitored throughout their experience.
Learn more about the importance of clinical trials.
Amy Rovitelli, senior regulatory coordinator, left, with senior health project coordinators Robin Boerman and Erin Cebula help lead Wilmot’s Clinical Trials Office.
How do they work?
Trials usually take place in phases. Phase 1 and 2 trials typically are designed to evaluate a treatment’s safety and the proper dose. Some newer, early-stage trials also enroll patients based on the unique molecular characteristics of their tumors, to test therapies that target those molecular characteristics. Phase 3 trials usually confirm a treatment’s effectiveness and compare it to standard care.
Investigators (the doctor or scientist in charge of the trial) are continually designing new trials to find ways to personalize cancer care. Clinical trials have eligibility requirements, and the best way for a patient to ensure that he or she is eligible is to discuss the trial with a doctor.
Some patients are concerned about receiving a placebo in a clinical trial. The vast majority of cancer trials do not use a placebo (a sugar pill, or the equivalent of no treatment). Instead, they compare the best standard treatments with standard care plus a new drug, or they enable patients with fewer options to receive the latest experimental therapies. It is a myth, however, that clinical trials are only for people with advanced cancer.
How are patients protected?
Institutional rules at the University of Rochester and federal regulations are in place to protect patients who take part in clinical trials. However, it’s important to clearly understand the objectives of a trial and to realistically plan for all possible outcomes, including a disappointing result or even death. No one is ever placed in a study without his or her knowledge, and all eligible patients will receive a consent form to review before agreeing to begin. We encourage anyone interested in a clinical trial to discuss this option with family and their physicians.
Most patients don’t incur additional costs to participate in trials. The trial provides the therapy and the oncologist bills insurance for office visits, blood tests, and other forms of standard care.
For more information, go to the National Cancer Institute’s clinical trials information page.
To find more clinical trials available at the University of Rochester, go to clinicaltrials.gov and enter the name of the cancer and Rochester in the search bar (i.e. “lymphoma” Rochester).