NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’

Regulatory NewsRegulatory News | 18 January 2019 |  By 

The center charged with coordinating the development of the National Evaluation System for health Technology (NEST) released a long-awaited “strategic and operational plan for 2019” on Friday.

The committee governing the NEST Coordinating Center (NESTcc) approved a four-pronged 2019 action plan, which involves two “key areas” in which NESTcc “has refined its direction.” These relate to developing the NESTcc data network and planning for the center’s own sustainability. The remaining aspects of the plan involve establishing NESTcc’s governance and ensuring stakeholder engagement.

The center’s plan was approved “in an effort to further advance our mission to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence (RWE) and innovative research,” said NESTcc executive director Rachel Fleurence.

The approval marks a step in the direction of operationalizing NESTcc by year’s end, which is when the US Food and Drug Administration (FDA) committed to opening the center. It is mutually funded by both industry user fees and FDA. Its success is reportedly hinging on an additional $46 million in funding.

Jeff Shuren, director at FDA’s Center for Devices and Radiological Health (CDRH), traveled across the country and stressed throughout 2018 that most if not all of CDRH’s major policy initiatives are heavily reliant on NESTcc’s successful development. Shuren, who also serves as a member of the NESTcc governing committee, recently identified certain measures of success for NESTcc version 1.O in 2019. 

On the NESTcc data network, Fleurence further noted that the plan also calls for exploring an expansion and “incorporating data sources from outside the United States.” This coincides with the idea NESTcc governing committee members, including Shuren and NESTcc chair Michelle McMurry-Heath, recently discussed regarding the potential for extending the application of NEST learning on a global scale.

“In addition to these NESTcc-funded test-cases, we will also be developing a process for the first non-NESTcc funded project to utilize the data network in an effort to expand the data network’s scope and test its scalability,” Fleurence added. The results of first round of test cases will be released this year.

Other new activities set for the beginning of 2019 under NESTcc’s new plan include launching new Active Surveillance Task Force by the end of January, as well as releasing an initial data quality framework and a methods playbook for the use of real-world data in NESTcc studies by this summer.

“Our key strategic priority in the area of stakeholder engagement for 2019 is to firmly establish NESTcc with a front door to conduct RWE studies,” Fleurence said. “This goal will be achieved through enhancing the NESTcc brand by strategically targeting key stakeholders and soliciting feedback on our aforementioned data quality and methods frameworks.”

A Look Ahead to What’s Next for NESTcc in 2019


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