What if the National Patient-Centered Clinical Research Network (PCORnet) teamed up with another robust distributed research network to combine powers in the pursuit of clinical research? Could researchers use the linkage to enhance complete data for surveillance and glean insights that allow people to make better informed, evidence-based decisions on important health-related matters? A new collaboration seeks to answer these questions.
Two pilot projects funded through a public-private partnership with the Patient-Centered Outcomes Research Institute (PCORI), the U.S. Food and Drug Administration (FDA), and the Regan-Udall Foundation (participating in an advisory capacity) are demonstrating the value of data linkage between PCORnet—one of PCORI’s most innovative initiatives to revolutionize clinical research—and other disparate distributed networks, such as the FDA’s Sentinel program. While PCORnet predominantly contains Electronic Health Record (EHR) 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. Altogether, this collaboration seeks to advance patient-centered research in regulatory science and enhance patient-clinician decision-making.
“We are delighted to be teaming up with the FDA, the Sentinel Initiative, and Reagan-Udall Foundation for this exciting and promising initiative that speaks to the future of patient-centered research and PCORnet’s value with researchers and other stakeholders,” said Joe Selby, M.D., M.P.H., executive director of PCORI. “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.”
The two pilot projects began in November 2016 and involve researchers in partnership with PCORnet’s OneFlorida Clinical Data Research Network and Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN).
OneFlorida Project: Planning for Congenital Zika Syndrome Surveillance in PCORnet and Sentinel
The first 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.
CAPriCORN Project: Initiatives to Monitor Exposure to Antimicrobials in PCORnet and Sentinel (DataMIME)
The second pilot project 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 (CDC) 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.
The FDA and PCORI are providing separate funding for both pilot projects, which are expected to conclude in autumn of 2018.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.