Overview
Mission
The mission of the National Evaluation System for health Technology Coordinating Center (NESTcc) is to catalyze the timely, reliable, and cost-effective development of real-world evidence (RWE) to enhance regulatory and clinical decision-making.
Vision
NESTcc’s vision is to be the leading organization within the health technology and medical device ecosystem for conducting efficient and timely high-quality RWE studies throughout the total product life cycle (TPLC).
Role
NESTcc serves a dual role in the medical device ecosystem:
As a coordinating center offering services to organizations seeking to sponsor medical device/technology research based on high-quality real-world data (RWD).
As a collaborative community comprised of representatives from across the medical device ecosystem, including FDA, working together to coalesce teams of diverse stakeholders around common needs and initiatives.
Daniel Caños, PhD, MPH, Director, Office of Clinical Evidence and Analysis, OPEQ, CDRH, FDA, discusses the aim of NEST and the role of NESTcc in advancing real-world evidence.
History
A Planning Board convened by the Duke-Margolis Center for Health Policy in late 2015 envisioned NEST as a voluntary network of data partners able to efficiently consolidate RWE to inform medical device evaluation and support regulatory decision-making throughout the total product life cycle (TPLC).
In September 2016, FDA awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC). MDIC is a 501(c)(3) public-private partnership with the objective of advancing approaches that promote patient access to innovative medical technologies. The selection of a third-party entity was important given the need for NESTcc to establish relationships and agreements between partners in a neutral, objective manner and to solicit a balanced representation from stakeholders.
In 2017, NESTcc established its inaugural Governing Committee, comprised of stakeholders across the medical device ecosystem. In the years since, NESTcc has led a number of initiatives to advance the innovative use of Real-World Evidence.
September 2016
FDA awards MDIC grant for NESTcc
July 2017
NESTcc establishes Governing Committee
February 2018
NESTcc announces full portfolio of Demonstration Projects
Read more about NESTcc’s Demonstration Projects.
April 2018
NESTcc establishes Research Network
Read more about the Network Collaborators in the NESTcc Research Network.
November 2018
NESTcc announces eight initial Test-Case research projects
Read more about the NESTcc Test-Cases.
June 2019
NESTcc announces 12 additional Test-Cases
Read more about NESTcc’s Test-Cases.
December 2019
NESTcc accepts proposals for development of active surveillance cloud infrastructure
February 2020
NESTcc publishes Data Quality and Methods Frameworks
Read more about the Frameworks.
June 2020
NESTcc opens for sponsored research opportunities
Read more about the launch.
July 2020
NESTcc adds first international Network Collaborator
Read more about the Network Collaborator.
October 2020
NEST announces Collaborative Community UDI initiative
Read more about the UDI Initiative.
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