FDA pilots 'first-of-its-kind' platform for sharing cancer trial PRO data
The US FDA has announced its pilot launch of a 'first-of-its-kind', online platform to publicly communicate and share patient-reported outcome (PRO) and symptom data from cancer clinical trials of marketed therapeutics.
The US FDA has announced its pilot launch of a 'first-of-its-kind', online platform – Project Patient Voice – to communicate and share patient-reported outcome (PRO) and symptom data from cancer clinical trials of marketed therapeutics with the public.
The platform, an initiative of the FDA’s Oncology Center of Excellence, will represent the first time that patients and healthcare professionals will have access to these patient-reported data, which have historically been analyzed and incorporated by the agency during drug approval processes but have rarely been included on products’ labels.
Amy Abernethy, Principal Deputy Commissioner at the FDA, explained: “Project Patient Voice has been initiated…to give patients and health care professionals unique information on symptomatic side effects to better inform their treatment choices. The…pilot is a significant step in advancing a patient-centered approach to oncology drug development.”
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During clinical trials, PROs may be collected through surveys and questionnaires that patients are asked to complete, which are designed to capture important symptomatic information such as the severity or frequency or a particular treatment side effect.
For the pilot phase of the initiative, information from one clinical trial only – pertaining to AstraZeneca’s Tagrisso (osimertinib) for use in EGFR mutation-positive, advanced non-small-cell lung cancer – will be available on the project’s website as the FDA gathers feedback on the usability and readability of the data.
For clinical trials listed on the site, patients will be able to access information on symptoms of trial participants before and during their first 6 months of treatment with the specified drug; patients will be able to see whether trial participants displayed symptoms before initiating treatment and which symptoms worsened during treatment.
“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,” commented Paul Kluetz, Deputy Director of the FDA’s Oncology Center of Excellence.