FDA Launches Pilot Program on Patient-Reported Outcomes

July 08, 2020 by Alec Stone MA, MPA, ONS Public Affairs Director

Facilitating the provision of patient-centered care is an ONS priority. But until recently, quality information from the patient’s perspective was limited. This kind of information is often unavailable, limited in its breadth, or solicited from patients too late in the healthcare process, making their experience less understandable than necessary. In response, the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) created a pilot program, called Project Patient Voice, that will make patient-reported symptoms from cancer trials available to the public.

According to FDA, clinical trial participants complete questionnaires to record data about disease- or treatment-related symptoms, including how severe or how often a symptom or side effect occurs. As more data are collected, FDA will make patient-reported outcomes available to the public so patients and caregivers can determine the best plan for an individual.

“Project Patient Voice has been initiated by OCE to give patients and healthcare professionals unique information on symptomatic side effects to better inform their treatment choices,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said. “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.” 

The program’s website will include a list of cancer clinical trials, and FDA is seeking public feedback regarding the project at a virtual public workshop on July 17. 


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