FDA's Sentinel Initiative - News and Events
FDA is committed to an open public process that will enable information to be disseminated and stakeholder contributions to be gathered as it explores the scientific, technical, and policy issues that will affect the Sentinel System’s development.
Brookings Roundtable on Active Medical Product Surveillance
Likelihood Ratio-Based Tests for Longitudinal Drug Safety Data
Join the Engelberg Center for Health Care Reform in an upcoming webinar, "Likelihood Ratio-Based Tests for Longitudinal Drug Safety Data," on Friday, October 24, 2014, from 10:00 AM - 11:00 AM EDT.
This webinar will highlight a recent development of longitudinal likelihood ratio test (LongLRT) methods with application to a pooled clinical trial dataset for drugs treating osteoporosis with concomitant use of proton pump inhibitors (PPIs). The assessment also considered the special case of LongLRT, referred to as sequential LRT (SeqLRT), which is utilized when evaluating a signal of an adverse event for a particular drug compared with a placebo or a comparator. Results suggested that concomitant use of PPIs could lead to more adverse events associated with osteoporosis. The performance of the proposed LongLRT and SeqLRT methods was evaluated using simulated datasets and shown to retain power and control of type 1 error over time. The proposed methods can also be applied to large observational databases with exposure information under the U.S. Food and Drug Administration's Sentinel Initiative for active surveillance.
Dr. Ram Tiwari, Associate Director, Immediate Office, Office of Biostatistics, Center for Drug Evaluation & Research at the U.S. Food and Drug Administration (FDA) and Dr. Lan Huang, Mathematical Statistician, Division of Biometrics V, Office of Biostatistics, Center for Drug Evaluation & Research at FDA will present an overview of findings from the development and its importance in the context of FDA's Sentinel Initiative.
Registration for this webinar is required. Please register at https://www.signup4.net/Public/ap.aspx?OID=130&EID=BROO33E.
Brookings Roundtables on Active Medical Products
Convened by the Engelberg Center for Health Care Reform at Brookings, roundtables provide a forum to discuss public and private initiatives that are developing methods, data sources, and technology relevant to active medical product surveillance. These roundtables are intended to ensure that a broad range of stakeholders are informed about and engaged in current and upcoming activities related to medical product surveillance. These one-hour conference calls/webinars are free and open to the public.
To view previous webinars, please click on the link below:
Sixth Annual Sentinel Initiative Public Workshop
Tuesday, January 14, 2014, 9:00 a.m. - 4:00 p.m.
Marriott at Metro Center | 775 12th St NW | Washington, DC
This public workshop, hosted by the Engelberg Center for Health Care Reform at The Brookings Institution, brought together stakeholders engaged and interested in the work of the U.S. Food and Drug Administration's (FDA) Sentinel Initiative. This year's event included presentations and panel discussions on a variety of topics including:
- An overview of the state of the Mini-Sentinel pilot program;
- Next steps for the Sentinel Initiative;
- Sentinel as a critical component of the emerging national health infrastructure; and
- Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety.
Event summary and materials are available at http://www.brookings.edu/events/2014/01/14-sentinel-initiative-public-workshop
Fifth Annual Sentinel Initiative Public Workshop
Thursday, January 31, 2013, 9:00 a.m. - 4:00 p.m.
Washington Marriott Wardman Park | 2660 Woodley Road | Washington, D.C.
Hosted by the Engelberg Center for Health Care Reform at Brookings, this public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including the following:
- An update on the U.S. Food and Drug Administration's Sentinel Initiative, including current activities and future plans;
- An overview of findings from Mini-Sentinel protocol based evaluations;
- Discussion of current and future collaborations and initiative expansions; and
- Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety issues that require regulatory actions.
Event summary and materials are available at http://www.brookings.edu/events/2013/01/31-sentinel-public-workshop
Fourth Annual Sentinel Initiative Public Workshop
Wednesday, January 18, 2012, 8:30 a.m. - 12:30 p.m.
Washington Marriott at Metro Center | 775 12th Street NW | Washington, DC
Hosted by the Engelberg Center for Health Care Reform at Brookings, this half-day public workshop brought together the stakeholder community for a productive discussion on the future direction of the U.S. Food and Drug Administration's (FDA) Sentinel Initiative, including remarks from FDA leadership about near-term priorities; an update on Mini-Sentinel's accomplishments in 2011; and comments from stakeholder representatives on Sentinel's progress.
Event summary and materials are available at http://www.brookings.edu/events/2012/01/18-sentinel-public-workshop
Third Annual Sentinel Initiative Public Workshop
Wednesday, January 12, 2011, 8:30 a.m. – 4:30 p.m.
Hosted by the Engelberg Center for Health Care Reform at Brookings, this one-day public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including:
– An update on Mini-Sentinel and related activities;
– Near-term plans for FDA's Sentinel Initiative; and
– Opportunities for coordination with other U.S. Department of Health and Human Services’ efforts that use distributed systems of automated health care data.
Event summary and materials are available at http://www.brookings.edu/events/2011/01/12-sentinel-workshop
Second Annual Sentinel Initiative Public Workshop
January 11, 2010, 8:30 a.m. – 4:45 p.m.
Washington Marriott at Metro Center, 775 12th St, NW, Washington DC
On January 11, 2010, the Engelberg Center for Health Care Reform at Brookings will convene the 2nd Annual Sentinel Initiative Public Workshop in Washington, DC. Supported by a grant from Food and Drug Administration (FDA), this one-day workshop will communicate the current status and future vision of active medical product surveillance activities and explore stakeholder perspectives on a broad range of issues. The workshop will feature:
Sentinel Initiative: Structure, Function, and Scope: December 16, 2008
A day-long public workshop on FDA's Sentinel Initiative was held in Washington D.C. on December 16, 2008. The workshop was cosponsored by the Food and Drug Administration and the eHealth Initiative Foundation and convened by the Engelberg Center for Health Care Reform at the Brookings Institution. The workshop brought together a diverse group of stakeholders, including academia, government, patient, consumer, and provider groups, payers, industry, and other interested organizations. Participants were given an update on the Sentinel Initiative’s status and their comments were welcomed. Discussion topics ranged from potential governance models and their implications to approaches for ensuring continued involvement of all stakeholders as the Initiative evolves.
Sentinel Network Public Meeting: March 7 and 8, 2007
A two-day public meeting that brought together stakeholders to begin discussions on creating a Sentinel system was held in Washington, D.C. on March 7 and 8, 2007. The meeting’s purpose was to:
- evaluate current needs in postmarket medical product adverse-event data collection, risk identification and analysis;
- better understand and identify gaps between what a range of stakeholders are doing and what they would like to do; and
- determine obstacles to facilitating or providing incentives for the creation of components needed to close the gaps and connect these various efforts into a Sentinel system.
The meeting also sought to identify opportunities for public-private collaborations for assembling data and conducting research and analysis.