What's Happening with Sentinel

CHOC Tapped for Mental Health Expertise on National AI Project Involving Electronic Medical Records
Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development
The Sentinel System has integrated the capability to perform sequential surveillance into its routine analytic tools. The tools have the ability to perform multiple executions of cohort or self-controlled risk interval analyses. This project aims to leverage these capabilities to assist FDA in their response to the COVID-19 pandemic – specifically monitoring safety of new therapeutics. The Sentinel Operations Center has posted a final draft of the study protocol for public comment. Comments must be received by the Sentinel Operations Center no later than December 1, 2023.
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The Centers for Medicare and Medicaid Services (CMS): Medicaid and Children’s Health Insurance Program (CHIP) Claims in Sentinel Common Data Model (SCDM) Format
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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Optimizing the Use of Postapproval Pregnancy Safety Studies: A Two-Day Public Workshop

The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, convened a two-day Public Workshop to gather stakeholder input on how to optimize the design and type of postapproval pregnancy safety studies of drugs and biologics regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The workshop took place on Monday, September 18, 2023 and Tuesday, September 19, 2023.

 

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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

63.3 million members are currently accruing new data in Sentinel
Approximately 63.3 million members are currently accruing new data in Sentinel
Key Database Statistics
Since the founding of the Sentinel Initiative in 2009, 227 scientific papers have been published
Since the founding of the Sentinel Initiative in 2009, 227 scientific papers have been published
Scientific Publications
Since 2016, more than 45 Sentinel drug studies have contributed to FDA regulatory actions or discussion
Since 2016, more than 45 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

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