News and Highlights
Drs. Rainu Kaushal and Alvin Mushlin are Site Principal Investigators for the FDA’s
Rainu Kaushal, MD, MPH, the Frances and John L. Loeb Professor of Medical Informatics and Chairman of the Department of Healthcare Policy and Research, and Alvin I. Mushlin, MD, ScM, the Nanette Laitman Distinguished Professor of Public Health in the Department of Healthcare Policy and Research and Professor of Medicine, are the Weill Cornell Medical College site Co-Principal Investigators on the contract from the U.S. Food and Drug Administration (FDA) to establish the Sentinel System, which aims to develop a nationwide capability to monitor the safety and effectiveness of drugs and other medical products. The $150 million contract is being led by Harvard Pilgrim Health Care Institute. Weill Cornell is one of more than 50 health care and academic organizations across the nation which are partnering on this important undertaking, which will use electronic healthcare data to establish the capability for post-marketing surveillance. The Sentinel partners, including Weill Cornell Medical College, will be eligible for funding for specific projects that are central to its aims.
The Sentinel project was preceded by the Mini-Sentinel, a five-year, $120 million pilot project that used electronic healthcare data for millions of patients to assess the risks of marketed medical products. The pilot protected the confidentiality of individuals’ medical information through partnerships with 18 health plans and provider organizations that maintained control of their own records. Using its distributed data network and analytic tools, the FDA now routinely runs hundreds of queries a year using the tools and data developed in the Mini-Sentinel project to investigate safety concerns about FDA-regulated medical products. These methods and infrastructure are now being adopted by other research networks sponsored by the Patient-Centered Outcomes Research Institute (PCORI) and the National Institutes of Health.
Dr. Mushlin was the Weill Cornell site Principal Investigator of the Mini-Sentinel project. He has been a participating member of its Planning Board and led the Mini-Sentinel subcontract titled “Foundational Elements: Anonymous Linking of Distributed Database Environments.” This work was performed in conjunction with the Weill Cornell Centers for Education & Research on Therapeutics (CERTs), which was funded by a grant from the Agency for Healthcare Research and Quality (AHRQ) to conduct research into the outcomes of medical and orthopedic devices.
The Sentinel System will enhance existing capabilities with the goal of addressing a larger array of questions for the FDA. In addition, the program may explore ways for other sponsors to use the program’s data infrastructure to address additional public health concerns, including the quality of medical care, the comparative effectiveness of medical treatments in common use, biomedical research questions, and a range of public health surveillance topics.
The participation of Weill Cornell Medical College in the Sentinel will also serve to link into the Sentinel project the New York City Clinical Data Research Network (NYC-CDRN), a PCORI-funded consortium to improve healthcare and healthcare delivery by studying anonymous patient data. Dr. Kaushal is the Principal Investigator of the NYC-CDRN.
“I am very happy that the work piloted by the Mini-Sentinel has been so successful and led to the fuller potential that the new Sentinel project provides,” said Dr. Mushlin. “The new expanded initiative represents a substantial step forward in helping the FDA to better monitor its regulated products and for academic institutions such as ours to do research on the safety and effectiveness of drugs and devices.”
“I am thrilled that the NYC-CDRN will be strengthened by this new association with the Sentinel initiative,” said Dr. Kaushal. “Our participation in the Sentinel will make us even better able to gather and analyze the healthcare data that we need to study and improve healthcare practices.”
“The FDA is pleased to see the pilot for the agency’s Sentinel System, dubbed Mini-Sentinel, begin its transition to a full-fledged program,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research. “The Sentinel System will play an integral role in expanding the resources we have to track and understand important information about the drugs used by patients throughout the United States.”“We are proud of the work accomplished with our many partners during the Mini-Sentinel program and are delighted to continue the next phase of this important work,” said Richard Platt, MD, MS, Professor and Chair of the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute.
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