Q+A: Clinical Trials
March 2, 2021
Brian Rini, MD, Ingram Professor of Cancer Research and chief of Clinical Trials at Vanderbilt-Ingram Cancer Center, is an internationally recognized leader in clinical drug development.
Q Why should a cancer patient participate in a clinical trial?
A Every drug that is FDA approved today has come through the clinical trials system, so we don’t get new drugs that help patients without conducting clinical trials. We need patients to participate in clinical trials so we can develop new drugs to help patients live longer. For the individual patient, clinical trials often offer access to drugs that are investigational and that patients can’t get outside of a clinical trial, in other words an additional option for patients. We don’t always help patients with every drug, but there are patients who have been helped dramatically. Immunotherapy clinical trials are a good example of that.
Q What types of trials are available at Vanderbilt-Ingram and typically how many are open?
A At any one time, we have over 200 clinical trials open across every cancer and disease state imaginable. One of our goals is to have a clinical trial available for every patient who walks in the door.
Q Do all clinical trials have a placebo arm where one group receives a new drug and another group receives standard of care? Are there clinical trials where everyone gets the investigational drug?
A There are many different types of clinical trials. In most trials that we do, they are not randomized, meaning all patients are getting the same treatment. That treatment might be investigational or might be standard therapy plus an investigational drug. There are some trials where patients are randomized, meaning patients get one treatment or the other. Rarely do those trials involve placebo. I would say that is a common misperception. For the vast majority of trials, all patients are getting potentially active drugs.
Q Where can someone find out more about clinical trials?
A I think the best resource is for patients to talk to their doctors because clinical trials are so dynamic, and they change all the time. There are many nuances about who might be eligible for a trial. It’s hard for doctors, and it’s really hard for patients, to go to a website and figure out what trials might be available. There is the Vanderbilt site as well as the clinicaltrials.gov website, which can be hard to navigate. I think patients are better served to come see us at Vanderbilt and then let us figure it out with them. Also, ask your doctor if there are clinical trials for you.
Q Does a clinical trial impact cost of care in any way?
A On a clinical trial, anything that is standard of care is billed to insurance: doctor visits, labs and scans. All the routine stuff that patients are going to get anyway is billed to the patient’s insurance. Anything that is being done solely for the purpose of the trial is built into the trial: any investigational drug, extra scans, extra labs, extra visits. Generally, that’s a clean division, but sometimes the cost of care can be affected.
Q Are there any misperceptions about clinical trials?
A People think clinical trials are only a last resort, that they should exhaust all standard options, then do clinical trials. That’s absolutely not true. Often, a patient’s very first anticancer treatment is part of a trial and the second round is part of a trial or the third one. It’s across all settings and all lines of therapy.
For more information about clinical trials, call 1-800-811-8480 or visit www.vicc.org/clinical-trials.