The Devil's in the Details: Reports on Reproducibility in Pharmacoepidemiologic Studies

Basic Details
Wednesday, March 6, 2019

The U.S. Food and Drug Administration's Sentinel Initiative “modular programs” have been shown to replicate findings from conventional protocol‐driven, custom‐programmed studies. One such parallel assessment—dabigatran and warfarin and selected outcomes—produced concordant findings for three of four study outcomes. The effect estimates and confidence intervals for the fourth—acute myocardial infarction—had more variability as compared with other outcomes. This paper evaluates the potential sources of that variability that led to unexpected divergence in findings.


Andrew B. Petrone, April DuCott, Joshua J. Gagne, Sengwee Toh, Judith C. Maro

Corresponding Author

Judith C. Maro, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Landmark Center, 401 Park Drive Suite 401, Boston, 02215 MA. Email: