FDA pilots program to communicate patient-reported cancer trials outcomes

The US Food and Drug Administration yesterday 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.

“Project Patient Voice has been initiated by the Oncology Center of Excellence to give patients and health care professionals unique information on symptomatic side effects to better inform their treatment choices,” said FDA Principal Deputy Commissioner Dr Amy Abernethy, adding: “The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development. Where patient-reported symptom information is collected rigorously, this information should be readily available to patients.”