FDA announces first of its kind program to communicate patient reported outcomes from oncology clinical trials

FDA announces first of its kind program to communicate patient reported outcomes from oncology clinical trials

July, 120

The U.S. Food and Drug Administration launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public.

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