FDA-backed NESTcc set to publish 2019 RWE strategy

Dive Brief:

The National Evaluation System for health Technology Coordinating Center (NESTcc) is set to publish its 2019 strategic and operational plan in the coming weeks.
NESTcc, a FDA-backed real-world evidence (RWE) group, is preparing the plan as it seeks to build on the advances it made in 2018, which it called its busiest year to date.
Last year, NESTcc teamed up with companies including Abbott and Johnson & Johnson to look into the use of RWE in regulatory processes.

Dive Insight:

NESTcc was established in 2016 with the support of a $3 million grant from FDA but it wasn't until last year that the organization really began to take off. In 2018, NESTcc brought together 12 healthcare organizations that collectively have access to almost 500 million patient records to create a network of collaborators.

Later in the year, NESTcc backed eight test cases to evaluate the use of these data resources. These test cases will use RWE to probe questions such as whether ablation catheters can treat cardiac arrhythmias.

Going into 2019, NESTcc and its collaborators are working to develop and select a second batch of test cases, according to an end-of-year letter from NESTcc Executive Director Rachael Fleurence dated Dec. 31. She said NESTcc received four times more submissions than when it called for the first batch of test cases, suggesting the idea is catching on with the industry. Currently, the 12 organizations in NESTcc’s network of data collaborators are helping to develop the second set of test cases.

NESTcc has previously expressed a desire for the second set of test cases to involve more small- and medium-sized device companies and premarket projects. The RWE group is yet to reveal the final set of test cases but has said that it received submissions from a wider range of stakeholder groups and that they spanned both broad RWE questions and queries that will require patient generated data.

The test cases are intended to provide NESTcc with information on the feasibility of using RWE to support regulatory processes and show it can make it easier for companies to access the data they need. Fleurence wrote in the letter that the organization will share further details of how it intends to work toward those broad goals when it publishes its plan for 2019 in the coming weeks.