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In pilot of patient-reported outcomes project, FDA hopes to encourage ‘more rigorous’ data collection

Buildings 1 and 2 of the FDA campus

The U.K.’s largest drug company is the first to be included in a new Food and Drug Administration pilot program designed to make patient-reported outcomes from cancer clinical trials available to the public.

The FDA launched Project Patient Voice last week, with London-based AstraZeneca as the first participant. The first clinical trial listed is AURA3, a study of 419 patients originally launched in 2014 that compared the non-small cell lung cancer drug Tagrisso against platinum chemotherapy. The trial included the use of the Patient Reported Outcomes – Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire, which allows patients to report safety and tolerability information that is complementary to the assessments used by clinical trial investigators. Data on 102 patients were included.

Currently, the FDA cannot provide a figure of how many companies, drugs or clinical trials will be included in the pilot program, an FDA spokesperson wrote in an email, adding that no new clinical trials will be added in the coming weeks or months.

The spokesperson added that data to be considered in the project must be collected frequently in the first few months of therapy, have a high completion rate and include adequately assessed symptoms of interest based on the treatment and disease study.

“We recognize that this is not a feature of many existing trials that have supported approval, but we hope that creation of Project Patient Voice will encourage more rigorous collection of patient-reported symptoms and side effects,” the spokesperson wrote.

The FDA said that while it has historically analyzed data from PROs when assessing drugs for approval, they are rarely included in drug labeling and tend to be inaccessible to the public.

“Project Patient Voice has been initiated by the Oncology Center of Excellence to give patients and healthcare professionals unique information on symptomatic side effects to better inform their treatment choices,” said Amy Abernethy, the FDA’s principal deputy commissioner, in a statement. “The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development.”

Photo: FDA (via Flickr; photo free of copyright protection)

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