What's Happening with Sentinel

Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting: Sotagliflozin and Diabetic Ketoacidosis (October 31, 2024)
Update on FDA's Ongoing Evaluation of Reports of Suicidal Thoughts or Actions in Patients Taking a Certain Type of Medicines Approved for Type 2 Diabetes and Obesity
Research in Action Podcast: Transforming Public Health with Unstructured Data and NLP in FDA's Sentinel Initiative
Risk of Non-Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis

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
245 Publications
Since the founding of the Sentinel Initiative in 2009, 245 scientific papers have been published.
Scientific Publications
Since 2016, more than 75 Sentinel drug studies have contributed to FDA regulatory actions or discussion
Since 2016, more than 75 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.

Learn About the Community

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