James Tcheng is an interventional cardiologist and informatician, and serves as Director of the Duke Cardiovascular Databank, Director of Performance Improvement for the Duke Heart Center, and CMIO of the Duke Heart Network. His work focuses on harmonizing the clinical definitions, data constructs, and associated informatics of cardiovascular clinical terminologies across academia, regulatory agencies, the life sciences industry, professional societies, and standards organizations, to improve the capture, communication, interoperability, and analysis of healthcare information. He is a key investigator of the FDA Medical Device Epidemiology Network (MDEpiNet) and principal investigator of the Pew Charitable Trusts-sponsored project, Improving Healthcare Data Interoperability. He previously chaired the American College of Cardiology Informatics and Health IT Committee.
MDEpiNet: The Journey to Real World Evidence
Despite the federal electronic health record program, real-world clinical data largely remains locked in analog documents. This talk will describe the Medical Device Epidemiology Network (MDEpiNet), a public-private partnership that is leveraging the Coordinated Registry Network paradigm for the capture of high-quality clinical data for evidence generation.
Modernizing clinical trials is the U.S. FDA priority. As more diseases are being redefined based on genomic subtype, researchers have more novel targets and more opportunities to precisely modulate or even repair the basic biological drivers of illness. Precision guided medicines can demonstrate strong efficacy signals in early clinical trials, including in trials where small groups of patients are selected based on biomarkers or other criteria suggesting they’re likely to benefit. These trials can potentially allow earlier regulatory assessment of benefit and risk. When the FDA can make a positive approval decision, patients can gain earlier access to important new therapeutic options. To take advantage of these innovations, the FDA is also seeking new ways to modernize its approaches to accommodate these novel opportunities.