The National Evaluation System for health Technology Coordinating Center’s (NESTcc) 12 new real-world evidence (RWE) test cases marked its first active surveillance project—the US Food and Drug Administration’s (FDA) test case on synthetic mesh slings—and the first test case to involve a wearable, with the Apple Watch.
New in NESTcc’s portfolio is also the first research question submitted by a patient advocacy organization. Projects that will include patient-generated health data (PGD) and prospective data collection are new advancements in testing the capabilities of the NESTcc Data Network, as well.
“We are really trying to test the capabilities of the data network and some of that has to do with needing to diversify the types of projects and have a larger sample to test the operational pathways,” NESTcc Chief of Staff Rachel Rath said in an interview with Focus
NESTcc—an initiative of the Medical Device Innovation Consortium (MDIC)—nearly doubled its 2019 workload with the addition of the 12 new RWE test cases that build on the eight test cases NESTcc selected
last November. Its development has been partly funded by FDA since 2016 when the agency granted MDIC $3 million, followed by $30 million over five years from industry user fees.
Active Surveillance Project
But the first active surveillance project to be selected by NESTcc kicks offs FDA’s involvement in executing an RWE test case with NESTcc’s network collaborators, which include Vanderbilt University Medical Center, Lahey Hospital & Medical Center, Mayo Clinic, MDEpiNet and Yale-New Haven Hospital.
The project, dubbed the Synthetic Mid-Urethral Slings for Stress Urinary Incontinence (SUI) in Women, will assess whether data routinely collected in electronic health records (EHRs) can be used to evaluate long-term adverse events post-implantation of surgical mesh. By studying the benefits of using real-world data (RWD), it will support a more informed understanding of the safety profile of mesh for SUI.
The focus of the first active surveillance project coincides with FDA’s efforts to address the volume of adverse events linked to urogynecologic surgical mesh. An expert panel called
on FDA in February to consider adverse events in premarket reviews. In April, FDA ordered
all manufacturers to immediately halt sales and distribution of transvaginal repair surgical mesh.
The question that FDA chose to submit went through the same review process, the same selection mechanism and competed against all the other concepts that came in, Rath noted. “The reviewers and the selection team felt that it was important enough to float to the top,” she said. “It was a priority topic for FDA” and “we are excited to have an opportunity to have this initial active surveillance test case while we are launching the active surveillance workstream from an overarching perspective as well.”
Rath clarified that FDA’s test case is the first active surveillance project to start testing what structure could have the capacity to conduct an active surveillance test case.
“This first active surveillance project gives us the opportunity to test a model for conducting active surveillance within NEST,” Rath said. Yet it will not be the only one as additional active surveillance projects will come in the coming months. “A lot of the test cases are to the science and to answer scientific questions, but they are also to set up the appropriate structure to answer those questions,” Rath added. “We will probably be looking at a handful more of active surveillance projects by the end of 2019,” contingent on a roadmap currently being developed by the active surveillance task force that NESTcc launched in January. “FDA's case will test one model of active surveillance,” but NESTcc “will be wanting other models and mechanisms” too, she added.
NESTcc’s first test case to involve a wearable device comes as a result of its targeted request—issued in addition to the broader call in July 2018— to specifically look for projects that will be incorporating PGD.
The research with the Apple Watch ECG and irregular rhythm notification detection features will be a randomized, controlled trial and allocate either the Apple Watch or usual care to 150 patients with atrial fibrillation who will be followed for six months. It will inform apps’ effects on patient-reported outcomes and clinical use to then assess the Apple Watch’s ability to serve as a post-market ECG surveillance tool.
The Apple Watch project is “an extension of a demonstration project that was previously done,” said Rath. “Yale and Mayo had worked together on a similar demonstration project and they are now scaling that to work with Duke as well, so it is a nice example of a test case that is scaling capabilities.”
FDA last September granted
Apple’s de novo requests for the ECG and irregular rhythm notification detection features for use on the Apple Watch. Yet Apple is not an official partner on the NESTcc project.
The 20 projects in total cover the device total product lifecycle (TPLC) and leverage various data sources.
Another PGD project will assess the impact of a mobile-delivered prescription digital therapeutic device that delivers cognitive behavior therapy for patients with chronic insomnia and depression.
Another project will answer the first question submitted by a patient advocacy organization—the American Sleep Apnea Association—based on the PGD from patients with obstructive sleep apnea or central sleep apnea. This is also among the first projects in NESTcc’s portfolio that will include prospective data collection. All test cases in the first round only included retrospective data collection.
As NESTcc eyes launching
version 1.0 by year’s end, select test cases are charged with providing proof of concept to generate high-quality RWE across a broad range of devices via the coordinating center’s Data Network.
The new test cases follow on the heels of NESTcc’s new data quality and methods frameworks. Both frameworks were released
last month, with the opening of a public comment period set to close 21 June.