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

View Abstract

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.

Abbreviation
Clin. Pharmacol. Ther.
Publication Date
2019-10-20
Pubmed ID
31630391
Medium
Print-Electronic
Full Title
Reproducing Protocol-based Studies Using Parameterizable Tools - Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks.
Authors
Huang TY, Welch EC, Shinde MU, Platt RW, Filion KB, Azoulay L, Maro JC, Platt R, Toh S