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# Sentinel Tool Comparable to Protocol-driven Assessment: Study
- URL: https://www.fdaweb.com/sentinel-tool-comparable-to-protocol-driven-assessment-study/
- Published: 2016-07-27T12:00:00.000Z
- Updated: 2026-09-14T21:18:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136301

FDA’s medical product safety surveillance system, Sentinel, has passed the first performance test of its modular program tools as part of a multi-effort assessment to validate their usefulness as surveillance measures. The test was conducted by FDA and other research partners to determine the extent to which a newly developed, semi-automated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol-driven assessment. The results were published this month in a [journal article ](http://onlinelibrary.wiley.com/doi/10.1002/cpt.429/abstract?ref=fdaweb.com)in *Clinical Pharmacology & Therapeutics.*

The researchers examined whether the PSM tool could produce the same results as a more traditional customized protocol-driven assessment, also conducted within Sentinel’s distributed data network, that involved a comparison of angioedema risk between angiotensin-converting enzyme (ACE) inhibitors and beta-blockers. The protocol-driven assessment found an adjusted hazard ratio (HR) of 3.04 comparing angioedema inpatients initiating ACE inhibitors versus beta-blockers, whereas the PSM tool produced a HR of 3.14 by evaluating 2,211,215 eligible ACE inhibitor initiators and 1,673,682 beta-blocker initiators. “This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol-driven assessment,” the researchers say in their article.

“While this is only one example, it demonstrates that the use of a semi-automated analytic tool in the Sentinel distribute database can produce results similar to those of safety assessments that involve *de novo* programming,” the researchers write. “Results of both the PSM tool analysis and the prior protocol-based assessment are also consistent with previous studies performed in other administrative data sources and using other protocol-driven approaches.”