USA – FDA program to share patient-reported outcomes in cancer drug trials

The U.S. Food and Drug Administration announced a new pilot program Tuesday to share information on symptoms patients report while undergoing clinical cancer drug trials.

Project Patient Voice, an initiative from the FDA’s Oncology Center for Excellence, will feature a public website making available the data from patients taking part in cancer trials. The information will be voluntary submitted by companies that conduct the trials, according to a press release from the agency.

“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,” said FDA Principal Deputy Commissioner Amy Abernethy in the release.

Patient-reported outcome (PRO) data is gathered using questionnaires that patients complete during clinical trials, capturing information related to the frequency, and the severity of symptoms when undergoing treatment…