Real World Evidence (RWE) Demonstration Project for SWPDC

SWPDC was also awarded additional funding from the FDA PDC program for its RWE Demonstration Project.  This represents a collaboration between a large children’s hospital health system (TCH / BCM) and a NSF-funded Engineering Research Center (PATHS-UP at Texas A&M). PATHS-UP is focused on remote monitoring for diabetes and cardiovascular disease in underserved populations to develop, test, and validate the use of an EHR-based data network to support evidence generation for medical devices across the total product life cycle.

The SWPDC RWE demonstration project initially involves the extraction of longitudinal data for all pediatric diabetes patients across the health system, many of whom are utilizing continuous glucose monitors (CGM) for diabetes management.

This project is aligned with the strategic plans and goals for the National Evaluation System for health Technology Coordinating Center (NESTcc) of the public-private partnership, Medical Device Innovation Consortium (MDIC), as the systematic process deployed to validate and test the pathways for evidence generation is expected to produce a scalable model to inform an industry-wide roadmap toward the use of EHR-based data networks for the responsible access and use of practice data, in both the pre-market and post-market spaces.

Later stages of the project will utilize the infrastructure and information generated in the CGM test case in the post-market space to inform future pre-market applications, and will lead to the development of new remote monitoring devices as part of the PATHS-UP center at Texas A&M.

Leaders of the SWPDC RWE Demonstration Project:

Daniel DeSalvo
Balakrishna Haridas