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JAMA Oncology paper examined whether patients were willing to report their symptoms in multi-center clinical trials.

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Ethan Basch, MD, MSc

Ethan Basch, MD, MSc, director of the UNC Lineberger Cancer Outcomes Research Program and professor in the UNC School of Medicine, led the collaborative study published in JAMA Oncology, “Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials,” that examined whether patients were both willing and able to report their symptomatic adverse events in multi-center clinical trials.

For the study, researchers invited 361 patients enrolled in any one of nine U.S. multicenter trials for cancer treatments to self-report 13 common, symptomatic adverse events using an adapted patient-reported outcomes tool of the National Cancer Institute’s Common Terminology Criteria for Adverse Events using table computers at five visits.

Out of 1,280 visits during which patients had an opportunity to self-report, self-reports were completed at 1,202 for overall adherence of 93.9 percent.

They concluded that patients are willing and able to report their own symptomatic adverse events at clinic visits, and report more than investigators. They argued the approach may improve precision of adverse event reporting in cancer trials.

Lisa A. Carey, MD, UNC Lineberger member, physician-in-chief of the N.C. Cancer Hospital and the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research, was a co-author on the study.