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 website for the Project Patient Voice program will provide a list of of clinical cancer trials that have available patient-reported symptom data. Visitors to the site will be able to select symptoms from a table associated with each trial. Graphs will be available that visualize changes in symptoms from before the trial began (called baseline) and over the trial’s first six months of treatment.
Current FDA safety tables do not include information regarding symptoms at baseline, changes in symptoms over time, or information regarding patients who have not experienced particular symptoms prior to treatment.
The FDA will launch the new website in phases. Initially, the FDA will post only data from a single trial, while it seeks public feedback regarding the data presentation.
AstraZeneca, which is developing treatments for a variety of different cancers, is the first company to participate in the new venture. To start, the biopharmaceutical contributed patient data from its ongoing AURA3 trial (NCT02151981) for locally advanced or metastatic non-small cell lung cancer, which is comparing Tagrisso (osimertinib) to platinum-based chemotherapy.
The company will work with the FDA to display these data to the public in a way that both patients and healthcare professionals find useful and informative.
“There have long been calls to provide information to patients about how they may feel and function when receiving a cancer treatment,” said Paul Kluetz, MD, deputy director of the OCE.
“By initiating Project Patient Voice, we are moving towards standardized methods to display these outcomes, starting with patient-reported symptomatic adverse events,” Kluetz said. “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.”
Project Patient Voice data will complement other labeling information sources. It will neither replace clinician-reported safety information, nor should it substitute for the advice of a trained healthcare professional.
“Many groups, including FDA, would like patient experience data to be available to the public, but the drug label that describes the trial(s) lacks the flexibility (space, color) that an online solution can provide,” the FDA says on the project website.
The FDA will seek public feedback regarding this project at a virtual public workshop on July 17, co-sponsored with the American Society of Clinical Oncology. FDA officials and health care providers, as well as patients, health outcomes researchers, industry representatives, advocacy groups, and other stakeholders will discuss what considerations to take into account when designing trials that seek to obtain patient-reported outcomes.
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