FDA Initiates Pilot Program to Share Patient-Reported Outcomes from Cancer Clinical Trials

The website Project Patient Voice has been launched by the FDA, which is a new website that will share publicly available information on patient-reported outcomes from clinical trials for cancer.

The website Project Patient Voice has been launched by the FDA, which is a new website that will share publicly available information on patient-reported outcomes (PROs) from clinical trials for cancer. This pilot program is the first of its kind, announced the FDA.1

This initiative of the FDA’s Oncology Center of Excellence will make findings from PROs more accessible to the public; these data are normally reviewed during the drug approval process by the FDA but are rarely included in product labeling.

“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 Amy Abernethy, MD, PhD, principal deputy commissioner, FDA, in a statement. “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.”

During clinical trials for cancer treatments, patients are asked to complete questionnaires designed to collect important information about symptoms patients experience that may be related to the disease itself or study treatment. These PRO data help define how severe or often a symptom occurs.

These data provide additional information for health care professionals when discussing potential toxicities associated with cancer treatment. Because these data come directly from the patients themselves as opposed to clinician-reported safety, people can see when symptoms started prior to the initiation of treatment and at multiple time points during treatment administration.

This website will include a list of clinical trials for cancer that have PRO data available, and each trial will have a table of patient-reported symptoms. A series of bar and pie charts will be available for each symptom to describe the symptom at baseline and over the first 6 months of treatment. The information provided here will be able to share insights on the symptoms not seen in standard FDA safety tables, which can include existing symptoms before the initiation of treatment, symptoms overtime, and subsets of patients who did not have a specific symptom before initiating treatment.

Project Patient Voice is in the first phase of the pilot website, which will include only 1 clinical trial as the FDA seeks feedback on the presentation of these data. The feedback will help the FDA make decisions to improve the website so that the information is as user-friendly as possible.

Charts, graphs, and data included on the website have been voluntarily provided by drug companies funding the clinical trials. The company AstraZeneca is the first to provide PRO data to the FDA for Project Patient Voice for 1 of their FDA-approved treatments, and they are collaborating with the FDA to determine how to display the information in the most accessible way for health care professionals and patients.

This program is not expected to replace clinical-reported safety information included in drug labels, and the data in Project Patient Voice should not replace advice from a health care professional for patients. The website will act as a complement to the drug labeling rather than acting as a sole source of information to make medical care decisions based on.

“There have long been calls to provide information to patients about how they may feel and function when receiving cancer treatment. By initiating Project Patient Voice, we are moving towards standardized methods to display these outcomes, starting with patient-reported symptomatic adverse events,” stated Paul Kluetz, MD, deputy director of the FDA’s Oncology Center of Excellence. “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.”

The FDA is seeking public feedback on the pilot effort of Project Patient Voice during a virtual public workshop, which is co-sponsored by the American Society of Clinical Oncology. The “Clinical Outcome Assessments in Cancer Clinical Trials” workshop will take place on July 17, 2020, and will include health care providers, patients, health outcome researchers, industry, and advocacy groups, among other stakeholders.

As an intital venture, Project Patient Voice is analyzing the phase 3 AURA3 clinical trial (NCT02151981) of osimertinib (Tagrisso) versus platinum-based doublet chemotherapy as treatmen of patients with local advanced or metastatic non–small cell lung cancer with an EGFR mutation.2


  1. FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials. FDA. June 23, 2020. Accessed June 24, 2020. https://bit.ly/2Vcrrdx
  2. Project Patient Voice. FDA website. Accessed June 24, 2020. https://bit.ly/2B5e9Zm
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