Submitted by Renee Pridgen, Associate Director, DCRI
Duke Clinical Research Institute (DCRI) is the Coordinating Center for Medical Device Epidemiology Network (MDEpiNet) Public Private Partnership (PPP). The Principal Investigator for the grant supporting the MDEpiNet PPP is Mitchell Krucoff, MD. DCRI Clinical Operation Project Leader for the partnership is Britt Barham, and Terrie Reed is the DCRI Informatics Project Leader.
Over the last three months the team has worked with other partners to finalize the PPP Charter and establish the PPP governance structure. As part of that structure, the DCRI Clinical Research Informatics Group will promote development of an MDEpiNet Informatics Working Group to work collaboratively with internal and external stakeholders and set general data governance, data standards, and data access principles for registry-based trial development. One activity will be a demonstration project using data from the National Cardiovascular Device Registry, multiple EHRs, and other patient-centered data that can be linked to provide a less expensive and less complex method for answering questions of device safety and effectiveness.
In addition to the demonstration, the Clinical Research Informatics (CRI) staff has proposed a new Informatics-based work item to the International Medical Device Regulator’s Forum (IMDRF), a voluntary group of medical device regulators from around the world who have come together to accelerate international medical device regulatory harmonization and convergence. The proposed work item, approved by IMDRF in mid-September, will align the informatics principles developed as part of the MDEpiNet PPP with international governing bodies. One of the deliverables of the IMDRF work item will be Informatics Essential principle documents to be harmonized internationally. Topics to be included are data formats and definitions, data quality and reliability, data governance, and data access and security.
The MDEpiNet demonstration project is scheduled to be presented at an MDEpiNet think tank in February 2015.