June 23, 2017: The Sentinel System: A Case for Analysis Ready Data


Richard Platt, MD, Harvard Pilgrim Healthcare Institute

Jeff Brown, PhD, Harvard Pilgrim Healthcare Institute


The Sentinel System: A Case for Analysis Ready Data


Pragmatic clinical trial; Clinical research; Health Data; Electronic Health Records; FDA; Sentinel

Key Points

  • Sentinel provides analysis-ready data on the use, safety, and effectiveness of FDA-regulated medical products
  • The Sentinel System provides routine tools combined with robust data quality assurance practices
  • Sentinel merges public, private, and academic expertise to provide access to health data
  • Healthcare data is currently being accrued for 43 million people through FDA’s Sentinel Initiative
  • FDA’s Sentinel Initiative offers efficient protocol-based analyses and custom programs, optimized for routine use

The results of TSOS will be reviewed by the American College of Surgeons’ Committee on Trauma, which produces guidance and resources for the optimal care of injured patients.

Discussion Themes

How do you reconcile a semi-automated approach to data quality checks with the regulated approach of data source verification?

Sentinel has similar challenges to PCORnet: the EHR data is complicated to work through, so there is still work to be done.
Queries can be done in 3.5 days, which is exciting progress.

Creating ready-to-wear analytic tools (rather than one-of-a-kind custom tailored tools) should dramatically increase efficiency, but this might change the business model of the evidence generation.

We still need randomized trials, but we waste a lot of money on answering questions that people don’t care about as much, so Sentinel will help us to answer the right questions. Every time Sentinel is used, it will continue to improve.

For More Information

Read more about the Sentinel System at https://www.sentinelinitiative.org/

#pctGR, @FDA, @PCTGrandRounds, @Collaboratory1, #HealthData