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FDA turns to real-world evidence to improve regulatory process

Published on 05/09/18 at 11:56am

The FDA has announced its intention to incorporate real-world data elements to a greater degree into its regulatory decision-making framework in a bid to “answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials,” according to the agency’s Commissioner Scott Gottlieb.

The organisation is hoping to leverage a range of data sources including electronic health records, and billing, claims data and registry data in a bid to make more swift and robust decisions regarding the authorisation of drug and medical device products.

The FDA Reauthorization Act of 2017 provided the funding for the agency to assess the benefits that real-world evidence (RWE) would bring to the regulatory process, and where these data may be sourced from. Particularly, the Act has provided additional resources and helped to improve the Sentinel system the FDA employs in the evaluation of drug and biologic products.

“The FDA is now supporting the first randomized prospective intervention trial that makes use of information in the Sentinel system,” Gottlieb said in a blog post. “To take one practical new example of this application, the IMPACT-Afib trial will test an educational intervention to address the important public health problem of underuse of effective medications to reduce the risk of stroke in patients with atrial fibrillation. This proof-of-concept trial can serve as a prototype for future RWE trials.”

He added: “The goal is for this to ultimately help drive the development of safer, more effective devices and timelier patient access to those devices. It will also increase the value and use of real-world evidence to support the needs of multiple stakeholders in our healthcare system, including the detection of emerging safety signals. NEST [National Evaluation System for health Technology] may also eventually be used to facilitate reimbursement – the Centers for Medicare and Medicaid Services serves on the NEST Governing Committee – as improved data collection can help encourage coverage with evidence development.”

Matt Fellows

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