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July 10, 2020

Increased visibility into patient-reported outcomes during clinical trials through FDA initiative: Project Patient Voice

By GlobalData Healthcare

On 23 June, the FDA, in collaboration with its Oncology Center of Excellence, launched an initiative, Project Patient Voice, designed to advance development and regulation of oncology products and improve visibility into patient experiences for all types of cancers. As part of this project, patient-reported symptoms from cancer trials for currently marketed drugs will be publicly available as an information bank for healthcare providers, patients, and caregivers. The patient experience data, reported by participants enrolled in clinical trials, are aimed at complementing clinical safety data available to prescribers and other drug label information sources to help guide clinical strategies.

AstraZeneca is the first company to participate in this pilot program by sharing patient data from its ongoing AURA3 clinical trial (NCT02151981) for non-small cell lung cancer and will be the only trial to pilot the website currently. The publicly available web portal is designed to provide a summary of symptoms associated with the disease, the trial intervention, and also an in-depth analysis for each patient-reported adverse event captured in the trial. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a specialised outcome measurement system specifically designed to record patient-reported symptomatic adverse events during oncology clinical trials and is currently being used in the AURA3 trial. It may commonly be adopted as a means for symptomatic data collection in future oncological clinical trials. GlobalData expects this will have a considerable impact on future trial designs and adverse event monitoring.

Real-world evidence has been increasingly valued by payers and regulators for product approval and reimbursement decision making. With rising costs in healthcare and increased emphasis on value-based payment reform, GlobalData expects data available through Project Patient Voice may supplement the development of provider reimbursement frameworks globally, support global reference labelling for product approvals, and facilitate value-based pricing.

Limitations associated with this data collection methodology, such as subjectivity of collected data, potential response bias, and measurement non-standardisation, remain a concern. However, given the growing importance on patient-reported outcomes and value-based care, GlobalData expects this initiative will receive a favourable response from healthcare providers, pharmaceutical companies, patients, and other stakeholders. The FDA plans to conduct a public workshop on 17 July to gather feedback on the website from health outcomes researchers, industry representatives, patients, advocacy groups, and other stakeholders interested in the measurement of symptoms and functional outcomes.

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