Event Information

On September 5, the Engelberg Center for Health Care Reform hosted “Overcoming Statistical Challenges to the Reuse of Data within the Mini-Sentinel Distributed Database” to provide an opportunity for experts in the field to discuss the issue of data reuse and to identify a practical path forward to resolve the challenges. This meeting explored the scientific concerns of data reuse and proposed solutions and next steps for implementation within Mini-Sentinel.

The development of the Mini-Sentinel pilot for medical product safety surveillance marks an important expansion of surveillance capabilities, with the potential for delivering more rapid and actionable information to inform regulators, health professionals, and patients.  Accomplishing the goals of active medical product surveillance will require solutions for the statistical challenges presented within Mini-Sentinel.

Event Materials

• Participant List
• Data Reuse Summary FINAL

      

 

 

Event Information

The U.S. Food and Drug Administration’s Sentinel Initiative has made important strides towards developing a valuable tool that can actively monitor the safety of medical products. Productive and broad collaboration among stakeholders from public and private institutions has been instrumental to this success. Since the Initiative’s inception, patient and consumer organizations have provided valuable perspectives and input into Sentinel.

On March 1, the Engelberg Center hosted an expert workshop, “Patients and Consumer Engagement in FDA’s Sentinel Initiative,” to explore opportunities for further engagement of these stakeholders in the Sentinel Initiative. This meeting brought together representatives from patient and consumer advocacy organizations and FDA to do the following:

• Provide patients and consumers with an overview of the Sentinel Initiative;
• Discuss opportunities for further patient and consumer engagement; and
• Discuss concrete next steps for evolving patient and consumer engagement.

Transcript

• Agenda and Biographies (.pdf)
• Discussion Guide (.pdf)
• Mark McClellan Presentation (.pdf)
• Richard Platt Presentation (.pdf)
• Bray Patrick-Lake Presentation (.pdf)

Event Materials

• Patient Consumer Summary
• Agenda_Bio_ForPrint
• Discussion Guide_final
• Mark McClellan Presentation
• Richard Platt Presentation
• Bray Patrick Lake Presentation

      

 

 

Event Information

On October 25, the Engelberg Center hosted and expert workshop, "Understanding and Discussing the Implications of FDA's Sentinel Initiative," which focused on issues of importance for medical product developers.

This meeting brought together representatives to discuss the role of FDA’s pilot program, Mini-Sentinel, within FDA’s broader array of tools to monitor medical product safety and to discuss mechanisms for how developers could support and engage with FDA on Sentinel-related activities.

Learn more about Expert Workshops>>

Transcript

• Participant List (.pdf)
• BASIC 3 Summary (.pdf)
• Agenda (.pdf)
• Event Summary (.pdf)

Event Materials

• Industry Involvement_participant list_for distribution_alpha last name_FINAL
• BASIC 3 Summary20111017FINAL
• October 25_Agenda_FINAL
• Industry Summary_20120327_FINAL

      

 

 

Event Information

Three years ago, the U.S. Food and Drug Administration (FDA) launched the Sentinel Initiative, making significant progress in developing a system for conducting active surveillance of medical products.  On September 26-27, the Engelberg Center hosted an event to reflect on the progress of the Initiative to date, and to consider its future direction and sustainability.

This event brought together a diverse set of stakeholders to reflect on the progress of the Initiative made to date, and consider its future direction to ensure sustainability of the system and reliability of results generated, including:

• Potential pathways that others outside of FDA (e.g., industry, academic safety scientists, etc) can access the resources and tools developed through the Mini-Sentinel pilot;
   
• Alignment of national priorities for safety science methods research and development, and training opportunities for the next generation of safety scientists; and
   
• Development of a national resource for evidence development by identifying synergies with related initiatives

Transcript

• Agenda (.pdf)
• Participant Biographies (.pdf)
• Event Summary (.pdf)

Event Materials

• Sentinel Strategic Review Agenda
• Sept 26 27 Biographies
• Strategic Review Summary_final

      

 

 

Event Information

The U.S. Food and Drug Administration (FDA) is developing the capacity for active medical product surveillance, which will enhance the agency’s ability to monitor the safety of marketed medical products. This new capacity will come in the form of the Sentinel System, which is currently being piloted through a project known as Mini-Sentinel. Accomplishing the goals of active medical product surveillance will require further development of new and existing methods and tools.

On February 16, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss some of the most pressing methodological issues facing active medical product safety surveillance. At this workshop, experts from academia, the private sector, FDA and other government agencies discussed several topics, including:

• Appropriate analysis and interpretation of signals in the context of large sample sizes
• Analyzing horizontally and vertically partitioned data
• Evaluating the performance of active surveillance methods

Transcript

• Discussion Guide (.pdf)
• McClellan - PPT (.pdf)
• Racoosin - PPT (.pdf)
• Rothman - PPT (.pdf)
• Ten Have - PPT (.pdf)
• Normand - PPT (.pdf)
• Berlin - PPT (.pdf)
• Hornbuckle - PPT (.pdf)
• Schmid - PPT (.pdf)
• Malin - PPT (.pdf)
• Clifton - PPT (.pdf)
• Rassen - PPT (.pdf)
• Ryan - PPT (.pdf)
• Gagne - PPT (.pdf)
• Walker - PPT (.pdf)
• Meeting Summary (.pdf)

Event Materials

• Final Discussion Guide 2
• 01 McClellan
• 02 Racoosin
• 03 Rothman
• 04 Ten Have
• 05 Normand
• 07 Berlin
• 08 Hornbuckle
• 09 Schmid
• 10 Malin
• 11 Clifton
• 12 Rassen for posting
• 13 Ryan
• 14 Gagne
• 15 Walker
• Statistical and Epidemiological Issues Expert Workshop Summary 20110516 2

      

 

 

Event Information

The U.S. Food and Drug Administration (FDA) currently utilizes information from multiple sources to evaluate the safety of approved medical products. Active medical product surveillance is a new tool that will augment the Agency’s existing postmarket safety assessment process. Numerous issues make communicating active surveillance activities and associated findings challenging.

On November 17, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss issues pertaining to communication of medical product safety surveillance findings. Experts from both the private and public sectors discussed several topics including:

• Current statutory provisions and FDA activities regarding safety and risk communications;
• Stakeholder perspectives on and implications of active surveillance communication strategies (stakeholders included patients, consumers, health care providers, sponsors, data partners, payers, scientists, and media);
• Mechanisms for rapid communication that do not pre-empt journal publications with more complete analyses; and
• Strategies to educate patients, physicians, and other decision makers on how to interpret and apply active surveillance results.

Transcript

• Participant Biographies (.pdf)
• Discussion Guide (.pdf)
• Vaughan (.pdf)
• McCaughan - PPT (.pdf)
• Menighan - PPT (.pdf)
• Sweet - PPT (.pdf)
• Laine - PPT (.pdf)
• Curfman - PPT (.pdf)
• Zarin - PPT (.pdf)
• Meeting Summary (.pdf)

Event Materials

• Nov 17 Expert Workshop agenda and bios
• Final Discussion Guide
• Vaughan_final outline
• McCaughan_Final slides
• Menighan_Final slides
• Sweet_final slides
• Laine_Final slides
• Curfman_Final slides
• Zarin_Final slides
• Communicating Findings Expert Workshop 20110518

      

 

 

Event Information

On September 21, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss the most effective and efficient ways to carry out the signal refinement step of active medical product surveillance. For the purposes of the meeting, signal refinement was defined as the step of active surveillance after signal generation, when a potential association between a medical product and health outcome is identified, and before signal evaluation, where formal epidemiological analyses are implemented. Potential steps in signal refinement are shown in the diagram below.

Experts from academia, the private sector, and FDA discussed several topics including:

• Approaches to building a generalized framework for signal refinement applicable to a broad range of medical products
• Acceptable levels of uncertainty in signal refinement
• Data needs for signal refinement
• Methodological needs and approaches for signal refinement

1. Association between an oral anti-diabetes drug and acute myocardial infarction
2. Association between an injectable antibiotic drug (administered in an inpatient setting) and acute liver injury

Event Materials

• bios
• discussion guide
• 01_Racoosin
• 02_Session I_Walker
• 03_Session I_Morris
• 04_Session I_Santanello
• 05_Session I_Bate
• 06_Session II_Juurlink
• 07_Session II_Curtis
• 08_Session II_Lieu
• 09_Session II_Reich
• 10_Session III_Schneeweiss
• 11_Session III_Fireman
• 11_Session III_Ryan
• 13_Session III_DuMouchel
• Methods for Signal Refinement Expert Workshop Summary 20110516 3

      

 

 

Event Information

The Engelberg Center for Health Care Reform at Brookings hosted a small expert workshop to discuss legal issues in the development and implementation of FDA’s Sentinel Initiative for medical product safety surveillance.

The one-day workshop featured productive discussion and exchange of ideas with panelists representing government, academia, and the private sector on topics including:

• Protecting patient privacy in medical product safety surveillance;
• Appropriate human-subject protections for research use of Sentinel System data; and
• Addressing legal liability in medical product safety surveillance.

Event Materials

• bios
• slides
• Panel 2 Issue Brief
• Panel 3 Issue Brief
• Panel 4 Issue Brief

      

 

 

Event Information

An expert technical workshop was convened to discuss distributed data networks and their use in active medical product surveillance.

This one-day technical workshop identified key features of existing data networks conducting medical product safety surveillance; discussed data infrastructure needs for a future national active surveillance system; and discussed barriers and explored solutions to private data environment participation in active surveillance. The overarching goal of the meeting was to stimulate productive discussion and exchange of ideas on these topics.

Convened by the Engelberg Center for Health Care Reform at Brookings and supported by a grant from the Food and Drug Administration.

Event Materials

• meeting summary 1
• Data Networks Bios
• Panel I slides
• Response Panel slides
• Panel II slides

      

 

 

Event Information

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.

Event Materials

• Discussion Guide

      

 

 

Event Information

On June 3, the Engelberg Center hosted an expert workshop on setting priorities for methods research and development for active medical product surveillance.

This technical workshop focused on topics including lessons learned, current activities, and anticipated needs for methods research and development. Presentations from a wide range of key stakeholders – including representatives from the U.S. Food and Drug Administration, the Observational Medical Outcomes Partnership, and Mini-Sentinel – aimed to develop a practical agenda for advancing this work. 

Learn about our other Expert Workshops »

Transcript

• Participant Biographies (.pdf)
• Meeting Summary (.pdf)
• Discussion Guide (.pdf)
• Woodcock - PPT (.pdf)
• Racoosin - PPT (.pdf)
• Ryan/Madigan - PPT (.pdf)
• Nelson/Schneeweiss - PPT (.pdf)
• Platt - PPT (.pdf)
• Stang - PPT (.pdf)

Event Materials

• methods compiled bios 20110531 EW
• Setting Priorities_June 2011_summary
• Setting Priorities_Discussion guide_20110527
• Woodcock
• Racoosin
• Ryan Madigan
• Nelson Schweineiess
• Platt
• Stang