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New Guidance for Clinical Trial Participation by Cancer Patients Receiving a COVID-19 Vaccination

Neeraj Agarwal, MD
Neeraj Agarwal, MD

An international group of cancer clinical research experts reported new recommendations that receiving a COVID-19 vaccination should not preclude a cancer patient from participating on a clinical trial. Huntsman Cancer Institute physician-scientist and professor of internal medicine at the University of Utah, Neeraj Agarwal, MD, was part of this newly formed group who reviewed the data and provided recommendations to patients, doctors, research centers, and the pharmaceutical research industry on this critical, emerging issue.

For many cancer patients, clinical trials are an integral part of their care. Clinical trials test the safety and effectiveness of new drugs and treatments. Nearly all cancer treatments in use today began as a clinical trial. Participating in a clinical trial requires strict monitoring of how and when the drug is given and any side effects. There are also restrictions on other medications a patient may receive, as they could impact the results of the drug being studied. For these reasons, extensive plans are made at the start of a clinical trial to outline which patients may participate in the study.

Many cancer patients are now eligible for COVID-19 vaccination. Experts recommend cancer patients be prioritized for COVID-19 vaccination and encourage people with cancer to get the vaccine as soon as it is available to them. Yet the availability of the vaccine presented an urgent, new consideration for cancer patients who also wish to participate in clinical trials: whether receiving a COVID-19 vaccination might make them ineligible for certain clinical trials, or even jeopardize their ongoing treatment provided through a clinical trial.

Last week, the recommendations of this group were published in Nature Reviews Clinical Oncology. Led by Vivek Subbiah, MD, of MD Anderson Cancer Center, the group reviewed data and determined receiving the COVID-19 vaccination should not preclude the ability of a person to participate in a cancer clinical trial.

"Being on a clinical trial should not be a roadblock for our patients from receiving COVID vaccine. Unfortunately, there was no clear policy or guidance, which frequently resulted in delaying the receipt of the COVID-19 vaccine by cancer patients. This international working group of renowned investigators published these consensus guidelines to address this critical issue," said Agarwal.

The findings are expected to be used to update guidelines for cancer clinical trials and to help inform research centers, hospitals, and the pharmaceutical industry.

Learn more about clinical trials at Huntsman Cancer Institute.

Media Contact

Heather Simonsen
Public Affairs Senior Manager
Huntsman Cancer Institute
801 581-3194
public.affairs@hci.utah.edu

About Huntsman Cancer Institute at the University of Utah

Huntsman Cancer Institute at the University of Utah is the National Cancer Institute-designated Comprehensive Cancer Center for Utah, Idaho, Montana, Nevada, and Wyoming. With a legacy of innovative cancer research, groundbreaking discoveries, and world-class patient care, we are transforming the way cancer is understood, prevented, diagnosed, treated, and survived. Huntsman Cancer Institute focuses on delivering the most advanced cancer healing and prevention through scientific breakthroughs and cutting-edge technology to advance cancer treatments of the future beyond the standard of care today. We have more than 300 open clinical trials and 250 research teams studying cancer. More genes for inherited cancers have been discovered at Huntsman Cancer Institute than at any other cancer center. Our scientists are world-renowned for understanding how cancer begins and using that knowledge to develop innovative approaches to treat each patient’s unique disease. Huntsman Cancer Institute was founded by Jon M. and Karen Huntsman.

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