The Food and Drug Administration (FDA) announced Project Patient Voice, a first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials. Initiated by the FDA’s Oncology Center of Excellence, Project Patient Voice creates a source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments.
The Project Patient Voice website collects patient-reported outcome (PRO) data using questionnaires that patients complete during clinical trials and includes information about disease or treatment related symptoms and the severity of those symptoms or side effects. The website will then list cancer clinical trials that have available patient-reported symptom data. The FDA notes that this information provides insight into side effects not currently available in standard FDA safety tables.
The agency emphasizes that Project Patient Voice is not to replace clinician-reported safety information or advice from a health care professional, but rather to serve as a complement to FDA patient labeling and patient information. The FDA will seek public feedback on the project at a virtual public workshop on July 17.