Pilot Projects Link PCORnet, FDA’s Sentinel Program

May 19, 2017
Two pilot projects under way are seeking to demonstrate the value of data linkage between the Patient-Centered Clinical Research Network (PCORnet) and other distributed networks, such as the FDA’s Sentinel program.

Two pilot projects under way are seeking to demonstrate the value of data linkage between the Patient-Centered Clinical Research Network (PCORnet) and other distributed networks, such as the U.S. Food and Drug Administration’s Sentinel program.

While PCORnet predominantly contains electronic health record clinical data, Sentinel uses claims data to monitor the safety of regulated medical products, including drugs, vaccines, biologics, and medical devices. Both EHR and claims data offer valuable insights that, when combined, allow for a more complete picture of overall health.

Funded through a public-private partnership with the Patient-Centered Outcomes Research Institute (PCORI), the FDA and the Regan-Udall Foundation (participating in an advisory capacity), this collaboration seeks to advance patient-centered research in regulatory science and enhance patient-clinician decision-making.

The two pilots began in November 2016 and involve researchers in partnership with PCORnet’s OneFlorida Clinical Data Research Network and the Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN).

The OneFlorida project focuses on leveraging EHR and claims data to reduce transmission rates of the mosquito-borne Zika virus. While most people infected with the Zika virus will only experience mild or even nonexistent symptoms, women who are infected with Zika during pregnancy are at risk of having babies that suffer from a birth defect of the brain called microcephaly and other severe brain and birth defects. This project is working to develop a strategy for tracking the number of babies born with microcephaly within OneFlorida’s Clinical Data Research Network. Ultimately, the project team will categorize database information on infants born with microcephaly and work with the Sentinel team to enhance surveillance of congenital Zika syndrome.

The CAPriCORN pilot seeks to harmonize data on usage of antimicrobials, which include drugs such as antibiotics, antivirals and antifungals. Because most bacteria, viruses, and other microbes multiply rapidly, they can quickly evolve and develop resistance to antimicrobial drugs, making it challenging to treat and control the spread of infections from multi-drug resistant organisms. This project will use the PCORnet Common Data Model to develop an open source methodology that can help the Centers for Disease Control and Prevention National Healthcare Safety Network, the FDA’s Sentinel program and local hospital administrations detect and analyze pathogen trends and understand how best to minimize antimicrobial resistance.

 “Collaborations like this will be essential if we’re going to transform traditional clinical research, conduct definitive studies, and put people and other healthcare stakeholders in the driver’s seat to enable better informed healthcare decisions,” said Joe Selby, M.D., M.P.H., executive director of PCORI, in a prepared statement.

The FDA and PCORI are providing separate funding for both pilot projects, which are expected to conclude in autumn of 2018.

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