Project Patient Voice (PPV) is a program that will gather and make available online, patient-reported outcomes from cancer clinical trials. Launched by the U.S. Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE), it is the first program of its kind to communicate patient-reported outcomes information already collected in a cancer trial and analyzed during regulatory approval, said Paul G. Kluetz, MD, Deputy Director of the Center. Dr. Kluetz described the project in a keynote address at the NCCN’s Annual Patient Advocacy summit in Washington, DC.
Paul G. Kluetz, MD
The patient-reported outcomes, submitted to the FDA as part of trial data, will include symptomatic side effects of already-approved drugs, including the occurrence and severity of symptom information over time. The pilot project is focusing solely on symptomatic adverse events at this point, Dr. Kluetz said in an e-mail interview, because they are important to patients and can add novel information about a drug effect.
A next step for Project Patient Voice is a joint FDA-ASCO workshop to obtain feedback on how the symptom data are presented on the website. “We are very excited to be partnering with ASCO to host our fifth public workshop to advance clinical outcome assessments in cancer trials, Dr. Kluetz wrote.
Planned for July 17, the public workshop is intended to gather feedback on the website from health outcomes researchers, industry representatives, patients, advocacy groups, and other stakeholders interested in the rigorous measurement of symptom and functional outcomes. It will be accessible in person, on the FDA campus, and online. More information and a registration link will be uploaded to the OCE website as soon as available. ■
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