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

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.