NEST Seeks Medical Device Test Cases for Using Real World Evidence

Posted 05 December 2017 By Zachary Brennan

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The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices.

Background

In 2016, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) awarded a $3 million grant to the Medical Device Innovation Consortium (MDIC) to establish NESTcc.

The center's mission is to establish pathways whereby timely, reliable and cost-effective evidence can be established using real world data. Earlier this year, Rachael Fleurence was selected to serve as NESTcc's first executive director and a governing committee has also been established.

Jeff Shuren, director of CDRH, told companies in September to get involved early with NEST, which is expected to be fully operational by 2019.

Proposals

On Monday, NESTcc put out a call for input from medical device manufacturers for test cases using Real World Evidence (RWE) that could be implemented with NESTcc's nine initial data partners that represent more than 100 million patients.

"Test-cases are being sought to assess feasibility and are intended to explore the data partners' ability to capture the data needed to support a range of studies and analyses. It is expected that a number of these test-cases could develop into targeted NESTcc projects demonstrating the value of RWE for pre-market needs, such as label or indication expansions, or the development of objective performance criteria," the call for concepts says.

The proposal says the goals of the test cases are to: "(1) Explore the feasibility for industry to use Real-World Data sources offered by NESTcc's initial set of partners. Other sources of Real-World Data could be explored if needed (e.g., registries, de-identified claims data, patient-generated data). (2) Identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies)."

NESTcc says it will select up to 10 viable test cases by February 2018, with plans to begin executing the contracts in April 2018.

The center also put out another request for proposals to identify a contractor "to conduct an assessment of the strengths, limitations, and appropriate use of Real-World Evidence for informing pre-market and post-market decision-making for multiple device types and to determine whether current methods, systems, and programs for Real-World Evidence can generate reliable and timely evidence about the effectiveness or safety surveillance of devices."

And a third request for proposals seeks to identify a contractor to conduct a review of up to 10 case studies with analyses of the returns on investment, uses of real world data for regulatory decisions, and, if available, coverage decisions.

Opportunities for Engagement With NEST

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Categories: In vitro diagnostics, Medical Devices, Clinical, Postmarket surveillance, Preclinical, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA

Tags: NEST, NESTcc, real world data, real world evidence

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