FDA Program Shares PROs From Cancer Clinical Trials

August 11, 2020 by Alec Stone MA, MPA, ONS Government Affairs Director

Cancer clinical trials often collect patient-reported outcome (PRO) data, but the information is generally used just for that trial. Recognizing the value of making it available to healthcare providers everywhere, in July 2020, the U.S. Food and Drug Administration (FDA) launched Project Patient Voice (https://www.fda.gov/news-events/press-announcements/fda-announces-first-its-kind-pilot-program-communicate-patient-reported-outcomes-cancer-clinical), a pilot program designed to share clinical trial PROs on an easy-to-access website.

“Project Patient Voice has been initiated by the Oncology Center of Excellence (OCE) to give patients and healthcare professionals unique information on symptomatic side effects to better inform their treatment choices,” said (https://www.fda.gov/news-events/press-announcements/fda-announces-first-its-kind-pilot-program-communicate-patient-reported-outcomes-cancer-clinical) FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development.”

Through Project Patient Voice, FDA uses questionnaires to collect patient-reported outcome data during clinical trials. These questionnaires capture (https://www.fda.gov/news-events/press-announcements/fda-announces-first-its-kind-pilot-program-communicate-patient-reported-outcomes-cancer-clinical) crucial data about the severity and frequency of disease- or treatment-related symptoms and side effects.

“There have long been calls to provide information to patients about how they may feel and function when receiving a cancer treatment. By initiating Project Patient Voice, we are moving toward standardized methods to display these outcomes, starting with patient-reported symptomatic adverse events,” Paul Kluetz, MD, deputy director of FDA’s OCE, said (https://www.fda.gov/news-events/press-announcements/fda-announces-first-its-kind-pilot-program-communicate-patient-reported-outcomes-cancer-clinical). “We encourage sponsors to collect this data systematically and look forward to welcoming additional sponsor collaboration as we work to help further serve the patient community.”

Patient-centered care (https://voice.ons.org/topic/patient-reported-outcomes-pros) has long been an ONS priority (https://www.ons.org/make-difference/ons-center-advocacy-and-health-policy/position-statements/access-quality-cancer), and it’s one of the many reasons nurses are the most trusted profession. Project Patient Voice (https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice#trials) provides healthcare professionals with information on implementing the data in their work and a list of cancer clinical trials currently involved in the program.


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