What's Happening with Sentinel

Duration of Follow Up for New Molecular Entities Approved in 2022: First Descriptive Analysis
A Practical Overview of Real-Life Challenges Leveraging EHR Data for the FDA Sentinel System
Utilization Patterns of Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease (COPD): A Descriptive Analysis
Assessing Treatment Effects in Observational Data with Missing Confounders: A Comparative Study of Practical Doubly-robust and Traditional Missing-data Methods

Recent Activity

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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 Studies

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 include 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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16th Annual Sentinel Initiative Public Workshop

The Duke-Margolis Institute for Health Policy is hosting the 16th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the Food and Drug Administration on November 7, 2024. Participants will hear from Sentinel Initiative leadership on a range of key issues illustrated by exemplary use cases. Sessions will consider key progress made in - and upcoming opportunities for - the Sentinel System, BEST System, and the landscape of stakeholder engagement.

 

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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

Approximately 128.7 million members are currently accruing new data in Sentinel.
Approximately 128.7 million members are currently accruing new data in Sentinel
Key Database Statistics
254 Publications
Since the founding of the Sentinel Initiative in 2009, 254 scientific papers have been published.
Scientific Publications
Drug Studies Graphic Nov 2024
Since 2016, more than 85 Sentinel drug studies have contributed to FDA regulatory actions or discussion
Drug Studies

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 Operations 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

1. Innovation Center (IC)
2. 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. 

Explore the Centers