Healthcare Innovation June 25, 2020
Project Patient Voice website seeks to create consistent source of patient-reported symptoms from cancer trials
The U.S. Food and Drug Administration has launched a pilot project to make patient-reported outcome (PRO) data from cancer trials publicly available.
The goal of Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE), is to create 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.
“Project Patient Voice has been initiated by the Oncology Center of Excellence to give patients and healthcare...
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