Clinical Trials: What is Informed Consent, with Carolyn Runowicz, MD

Last Updated: August 20, 2018

Dr. Carolyn Runowicz introduces informed consent, a process that helps every patient understand the potential risks, benefits, and alternatives before they join a clinical trial.

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Patient Safety and Informed Consent

Clinical Trials

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Cancer.Net®: Doctor-Approved Patient Information from ASCO®

Clinical Trials

What You Should Know About Informed Consent

Carolyn Runowicz, MD: A cancer clinical trial is testing a new drug or a new product. And there are different types of clinical trials, some of them test the side effects, and some of them test the effectiveness against standard therapy. Informed consent tells the patient what the side effects are, what the potential benefits are, if there known, and so that a patient will enter into a clinical trial once they understand what the risks are, what the potential benefits are, and what the alternatives are to a clinical trial. For example, what's the standard therapy, and how might enrolling in this clinical trial be perhaps beneficial to the patient? Or if not to the patient, to future generations? And then, what are the known side effects and benefits of enrolling in the clinical trial? This is usually given verbally, and then also, the patient is given written information so they truly can make an informed consent. I think what's important for a patient, is to totally understand what they're signing up for, and what the alternative or standard of care is. At any point the patient can opt to opt-out of the clinical trial and go onto standard of care.

Why Should I Consider a Clinical Trial?

Dr. Runowicz: So, standard of care usually gives you the best treatment, but there are new drugs that come out and those new drugs could be more effective. So I'm a cancer doctor, but I'm also a cancer patient, who when I was faced with having breast cancer, the standard of care at that time did not include a drug that I ultimately got, and now today actually is standard of care. So through clinical trials, we really advance knowledge and care of patients. It may end up that it's not a better drug, that response rates are identical, or it could be that there's toxicity that you get that you wouldn't have gotten if you did standard. But, I think the potential to maybe personally gain, but also add to the science for future patients is very important in clinical trials.

Where to Get More Information

Dr. Runowicz: So if you're a patient looking for clinical trials you can go onto ASCO's website and learn about clinical trials, and learn what clinical trials you might be eligible for.

[Closing and Credits]

Cancer.Net®: Doctor-Approved Patient Information from ASCO®

ASCO's patient education programs are supported by Conquer Cancer Foundation of the American Society of Clinical  

Special Thanks:

Video Footage courtesy of: Rosewell Park Cancer Institute

Select photos courtesy of: University of Connecticut Health Center

Special thanks: Carolyn B. Hendricks, MD, The Center for Breast Health

The Adele R. Decof Comprehensive Cancer Center at The Mariam Hospital

The Miriam Hospital is a teaching hospital of The Warren Alpert Medical School of Brown University

The opinions expressed in the video do not necessarily reflect the views of ASCO or the Conquer Cancer Foundation.

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