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Clin Pharmacol Ther. 2019 Oct 20. doi: 10.1002/cpt.1698. [Epub ahead of print]

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

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Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States.
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.
Department of Medicine, McGill University, Montreal, Quebec, Canada.
Gerald Bronfman Department of Oncology, Montreal, Quebec, Canada.


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. Results from the replication new-user cohort analyses aligned with those from the CNODES nested case-control studies. The adjusted hazard ratios were 0.95 (0.81, 1.12) (versus 1.03 [0.87, 1.22] in CNODES) for acute pancreatitis and 0.91 (0.84, 1.00) (versus 0.82 [0.67, 1.00] in CNODES) for HF among patients without HF history. The CNODES's common protocol approach allows studies tailored to specific safety questions, while the Sentinel's common data model plus pre-tested program approach enables more rapid analysis. Despite these differences, it is possible to obtain comparable results using both approaches.


CNODES; Distributed data network; Sentinel System; drug safety surveillance; reproducibility; transparency


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