What's Happening with Sentinel

Adaptive Validation Designs: Premise and Methods
An internal validation substudy compares an imperfect measurement of a variable with a gold standard measurement in a subset of the study population. Existing guidance on optimal sampling for validation substudies has assumed complete enrollment and follow-up of a target subset with fixed size. The adaptive validation approach provides a framework to monitor validation data as they accrue until predefined stopping criteria for the goals of validation are met. The method provides an approach to effective and efficient estimation of classification parameters as validation data accrue and can be modified to meet alternative criteria given specific study or validation study objectives.
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About Sentinel

The U.S. Food and Drug Administration (FDA) leads the Sentinel Initiative. The main goal is to improve how FDA evaluates the safety and performance of medical products.

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How Sentinel Uses Data

The FDA uses Sentinel data to evaluate the safety of medical products. They also use Sentinel data to learn more about potential side effects.

Drug Assessments

How Sentinel Protects Privacy

Sentinel uses a distributed data approach. In this approach, data remain with the data owner, i.e., an insurance company. Also, data owners remove patient identifiers to protect privacy.

Privacy & Security

Where Sentinel Gets Its Data

Sentinel data come from existing sources. These includes insurance claims, electronic health records, and patient reports.

Who is Involved

What Data Sentinel Uses

Data from the health systems, insurance companies, or medical records can be used without personal information being shared to learn more about medical products.

Types of Data

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Sentinel Public Training on Maternal Health and Pregnancy

The Sentinel Public Training on Maternal Health and Pregnancy was held on Monday, November 2 from 9:00 AM to 12:00 PM EST.

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Methods, Data, & Tools

Sentinel has various methods and tools to support the evaluation of medical products. U.S. Food and Drug Administration (FDA) scientists use Sentinel data to complement their data and information.

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Data-Driven Impact

70,600,000
Approximately 70.6 million members are currently accruing new data in Sentinel
Key Database Statistics
190 scientific publications
Since the founding of the Sentinel Initiative in 2009, 190 scientific papers have been published
Scientific Publications
30
Since 2016, more than 30 Sentinel drug assessments have contributed to FDA regulatory actions or discussion
Drug Assessments

The Sentinel Community

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Data Partners & Collaborators

The FDA gets data for the Sentinel System through its Data Partners. The Data Partners are the ones who access, maintain, and protect the data in a distributed system. The Sentinel Coordinating Center partners with a network of collaborators. This includes Data Partners and Collaborating Institutions. Together, they provide healthcare data and scientific, technical, organizational expertise.

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Sentinel Structure

Three blue boxes representing the structure of Sentinel, including SOC, IC, CBOC

1. Community Building and Outreach Center (CBOC)
2. Innovation Center (IC)
3. Sentinel Operations Center (SOC)

These centers collaborate to advance regulatory science using the Sentinel System. However, each center operates independently and has a dedicated leadership team and staff. The three centers each carry out projects associated with their strategic objectives.

Explore the Centers