FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials

FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials
The U.S. Food and Drug Administration (FDA) has launched an initiative called Project Patient Voice to create a publicly available information bank describing patient-reported symptoms from cancer trials for marketed treatments. The initiative is a part of the FDA’s Oncology Center of Excellence (OCE), which is designed to advance the development and regulation of oncology products for all types of cancers. Although the FDA regularly analyzes patient-reported outcomes during its drug approval process, such information is rarely included in product labeling. That means that the information has not previously been easily accessible 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,” Amy Abernethy, the FDA's principal deputy commissioner, said in a press release. “The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development," Abernethy said. "Where patient-reported symptom information is collected rigorously, this information should be readily available to patients.” The value of patient-reported outcomes and how best to use them is an active topic of discussion within the scientific community. These data are frequently sought in clinical trials, through questionnaires that collect information such as the severity of symptoms, and side effects, and how often they occur. Information reported by patients themselves provides complementary data to observations made by clinicians. For instance, patients often can describe the onset of symptoms before their physical signs appear or before treatment starts. The
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