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Methods, Tools, and Scientific Operations for the Sentinel System

The FDA Amendments Act of 2007 (FDAAA) tasked the FDA with developing a system for monitoring the safety of FDA-regulated medical products after they reach the market. The law states this system, which would use electronic health data, should cover at least 100 million people by 2012.

FDA responded with a national strategy for monitoring medical product safety, known as the Sentinel Initiative. The goal of the Initiative is to create a national, integrated, electronic system (the Sentinel System) for monitoring medical product safety. FDA has said the system will be capable of querying existing distributed data sources — which would continue to be owned and maintained by their owners — quickly and securely for relevant de-identified product safety information. Sentinel is anticipated to leverage the capabilities of multiple existing databases of electronic health records and administrative claims.

For Sentinel to achieve its objective, it will be necessary to identify or develop specific processes and scientific methodologies to query and draw appropriate inferences from available data sources. These methods should facilitate the detection of higher-than-expected rates of adverse events in the general population (signals), as well as confirmatory analyses.

The Engelberg Center for Health Care Reform at Brookings, in cooperation with the Centers for Education and Research on Therapeutics (CERTs), convened a Think Tank to develop recommendations on the methods, tools, and scientific operations of the Sentinel System. The meeting content focused on anticipatable adverse events using routinely-collected, electronic, administrative claims and medical record data.

Agenda

Welcome and Think Tank Objectives

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

Sentinel Status Update

R

Rachel Behrman

Director, Office of Medical Policy, Center for Drug Evaluation and Research

Introduction: Scientific Methods and Operations

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Methodologic Considerations: The Use of Observational Data to Assess Safety

Signal Detection Methods for Active Post-Licensure Safety Surveillance (Hypothesis Generation)

Rapid Response Capabilities (Hypothesis Strengthening)

T

Tanja Popovic

Chief Science Officer, Centers for Disease Control and Prevention

Confirmation/Refutation: Signal Requiring Full Epidemiologic Analysis (Hypothesis Testing)

Organizational Needs to Support Scientific Operations

J

Judith Kramer

Executive Director, Clinical Trials Transformation Initiative

Review and Next Steps

Mark B. McClellan

Former Brookings Expert

Mark McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at Brookings. He has written a number of publications on care delivery reform, physician payment reform, and accountable care implementation in the U.S. and abroad.

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

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