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News From the Food and Drug Administration
August 3, 2021

Collecting Patient-Reported Outcomes in Cancer Clinical Trials

JAMA. 2021;326(5):379. doi:10.1001/jama.2021.12277

To help patients with cancer learn more about how treatment may affect their quality of life, the FDA has issued draft guidance on collecting information about patient-reported outcomes in cancer clinical trials.

“Patients would like to better understand symptoms they may experience and how a cancer therapy can affect their quality of life,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement. “One way to accomplish this is to ask patients in clinical trials about the severity of their symptoms and ability to function using rigorously developed patient-reported outcomes.”