On Tuesday, the FDA announced a new program called Project Patient Voice that aims to provide cancer patients with more information about their treatment options by making patient-reported outcome (PRO) data from clinical trials publicly available. PRO data is collected via questionnaires filled out by patients themselves. Until now, the publicly available data included in product labeling came entirely from clinician’s observations during clinical trials. According to an FDA press release, Project Patient Voice “serves as a complement to FDA patient labeling and patient information, not a sole source of information on which to make decisions about medical care.”
The first trial making PRO data publicly available through the program is for the drug osimertinib, sold by AstraZeneca as Tagrisso, which is used to treat non-small-cell lung carcinomas.