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Reproducing Protocol‐based Studies Using Parameterizable Tools – Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks

    Basic Details

    The U.S. Sentinel System and the Canadian Network for Observational Drug Effect Studies (CNODES) are two medical product safety surveillance networks. Using Sentinel’s pre‐programmed, parameterizable analytic tools, we reproduced two protocol‐based studies conducted by CNODES to assess the risks of acute pancreatitis and heart failure (HF) associated with the use of incretin‐based drugs, compared with use of ≥2 oral hypoglycemic agents.


    Ting‐Ying Huang, Emily C. Welch, Mayura U. Shinde, Robert W. Platt, Kristian B. Filion, Laurent Azoulay, Judith C. Maro, Richard Platt, Sengwee Toh

    Corresponding Author

    Ting‐Ying Huang, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States