FDA Announces Launch of Project Patient Voice

The FDA recently announced the launch of Project Patient Voice, a new website which creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments.

Though this patient-reported data has been historically evaluated by the FDA during the drug approval process, it has rarely been included in product labeling, and is therefore largely unavailable to the public.

“Project Patient Voice has been initiated by the Oncology Center of Excellence (OCE) to give patients and health care professionals unique information on symptomatic side effects to better inform their treatment choices,” Amy Abernethy, MD, PhD, principal deputy commissioner at the FDA, said in a press release. “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 using questionnaires that patients complete during clinical trials. The questionnaires are intended to capture relevant information about disease- or treatment-related symptoms, including how severe or how often a symptom or side effect occurs.

Making this patient-reported data available has the opportunity to provide additional, complementary information for health care professionals to discuss with patients, especially when discussing the possible side effects of a specific cancer treatment. In contrast to the clinician-reported safety data in product labeling, the data on this new website is collected directly from patients and can show symptoms before treatment starts and at multiple time points while receiving cancer treatment.

In the first phase of the Project Patient Voice pilot website, only 1 trial will be included while the FDA collects public feedback on how the information is being presented. The FDA will then use this feedback to consider necessary improvements to the website in order to make the information as user-friendly as possible.

The information included on the website will be voluntarily provided by the drug companies that conduct the clinical trials. AstraZeneca is the first company to provide patient-reported outcome data for 1 of their FDA-approved drugs and has worked in collaboration with the FDA to determine the most effective way to disseminate information to patients and healthcare providers.

“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,” Paul Kluetz, MD, deputy director of the FDA’s OCE, said in the release. “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.”

Once fully operational, 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, which when selected can display a series of bar and pie charts describing the patient-reported symptom at baseline and over the first 6 months of treatment.

According to the FDA, this information provides insights into side effects that are not currently available in standard FDA safety tables, including symptoms which existed before the start of treatment, symptoms that developed over time, and the subset of patients who did not have a specific symptom before starting treatment.

Notably, Project Patient Voice is not intended to replace the clinician-reported safety information that is already available as part of a drug’s labeling. Additionally, the information is not to be used as a substitute for guidance from a healthcare professional. Instead, the website is intended to serve as a complement to FDA patient labeling and patient information.

Reference:

FDA. FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials. FDA website. Published June 23, 2020. fda.gov/news-events/press-announcements/fda-announces-first-its-kind-pilot-program-communicate-patient-reported-outcomes-cancer-clinical. Accessed June 24, 2020.