FDA announce new pilot program to communicate patient reported outcomes for cancer clinical trials
FDA has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analysed by the FDA during the drug approval process, it is rarely included in product labelling and, therefore, is largely inaccessible 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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “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.”
Patient-reported outcome (PRO) data is collected via questionnaires that patients complete during clinical trials. These questionnaires are designed to capture important information about disease- or treatment-related symptoms. This includes how severe or how often a symptom or side effect occurs.
Patient-reported data can provide additional, complementary information for health care professionals to discuss with patients, specifically when discussing the potential side effects of a cancer treatment. In contrast to the clinician-reported safety data in product labelling, the data in Project Patient Voice is obtained directly from patients and can show symptoms before treatment starts and at multiple time points while receiving cancer treatment.
The Project Patient Voice website will include a list of cancer clinical trials that have available patient-reported symptom data. Each trial will include a table of the patient-reported symptoms collected. Each patient-reported symptom can be selected to display a series of bar and pie charts describing the patient
In the first phase of this pilot website, only one trial will be included while the FDA seeks public feedback on how the information is presented. The FDA will use this feedback to consider improvements to the website in order to make the information as user-friendly as possible.
The visualisations and data included on the website are voluntarily provided by the drug companies that conducted the clinical trials. AstraZeneca is the first company to provide patient-reported outcome data for one of their FDA-approved drugs and has collaborated with the FDA to identify methods to display the information in a way that is informative to health care professionals and patients.
“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 towards standardized methods to display these outcomes, starting with patient-reported symptomatic adverse events,” said Paul Kluetz, M.D., deputy director of the FDA’s OCE. “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.”