AventaMed selected as Test Case for RWE by NESTcc
The National Evaluation System for health Technology Coordinating Center (NESTcc) Announces New Real-World Evidence Test-Cases Solicited from Across the Medical Device Community
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ability to generate high-quality RWE for a range of medical devices through the NESTcc Data Network.
“These twelve projects constitute an exciting and diverse portfolio that tests the capabilities of NESTcc’s Data Network in pre-market and postmarket settings and complements the projects selected in the initial round in 2018,” according to NESTcc’s executive director, Rachael Fleurence, PhD. She notes that, “This set of projects includes a number of firsts for NESTcc, including the first prospective research projects that will utilize patient-generated health data (PGD), the first active surveillance project exploring the safety of synthetic mesh slings, and the first question submitted from a patient advocacy organization.”
In this round of Test-Cases, NESTcc has selected projects that reflect the diversity of types of medical devices available and the different uses of data in pre-market and postmarket settings. Research questions were solicited through a call for both Broad (non-PGD) and Targeted PGD submissions posted in July 2018.
Overall NESTcc received 40 concept submissions (25 Broad and 15 Targeted PGD) from 26 different organizations including health systems, government entities, medical device manufacturers, non-profits including patient advocacy organizations, and academic institutions. This marked a nearly four-fold increase in the number of concepts submitted in the initial round, which were awarded in October 2018. The Test-Cases will be executed through collaborations between NESTcc’s Network Collaborators and the organizations that submitted the concepts for project development. These include the medical device manufacturers Abbott Diagnostics, AventaMed, Becton Dickinson (BD), Cook Medical, Intrinsic Therapeutics, Medtronic, and Pear Therapeutics, as well as the U.S. Food and Drug Administration (FDA), the Women’s Health Technology Coordinated Registry Network (WH-CRN), Yale-New Haven Health Center for Outcomes Research and Evaluation (CORE), and the American Sleep Apnea Association (ASAA).
The new Test-Cases span the medical device total product lifecycle (TPLC) and include projects that have regulatory (i.e., pre-market and postmarket pathways) and coverage applications. NESTcc Network Collaborators will contribute to the execution of the projects by leveraging multiple data sources – device registries, electronic health records (EHR), claims, mHealth, PGD, and Patient Reported Outcomes (PRO).
“As part of ongoing efforts to modernize our approach to device safety, the FDA is striving to meet an important and aggressive goal that we set for ourselves: Ensuring that the agency is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health and a board member of MDIC. “These new test cases help show the potential for NEST to help reach the goal of systematically using real-world data to enable the efficient development of new, innovative medical devices and rapidly identify and address safety signals in a postmarket setting to keep patients safe.”
Read More: https://nestcc.org/12rwe-test-cases/