FDA's Sentinel Initiative - Ongoing Projects

FDA's Sentinel Initiative - Ongoing Projects

Contracts

• Detection and Analysis of Adverse Events related to Regulated Products in Automated Healthcare Data: Efforts to Develop the Sentinel Initiative (Mini-Sentinel)

This effort's aim is to develop the scientific operations needed for the Sentinel Initiative.  Specifically, FDA aims to create a coordinating center with continuous access to automated healthcare data systems that would have the following capabilities:

1. Provide a "laboratory" for developing and evaluating scientific methodologies that might later be used in a fully operational Sentinel Initiative.
2. Offer the Agency the opportunity to evaluate safety issues in existing automated healthcare data system(s) and to learn more about some of the internal and external barriers and challenges. 

For more information, visit the Sentinel website.

Cooperative Agreements

• Convener on Active Medical Product Surveillance - Key to continued broad-based support and momentum for effective, active medical product surveillance is maintaining a high degree of stakeholder outreach and involvement. The Agency awarded a cooperative agreement in order to convene a broad range of stakeholders to explore and address methodological, data development, technical, and communication issues related to active medical product surveillance. In addition to convening and moderating each meeting, findings will be synthesized and communicated to organizations and individuals that can use the information to further develop active medical product surveillance methods and systems. Four types of meetings are planned:

1. Expert Stakeholder Conferences will bring together expert stakeholders for in-depth discussions of safety science issues
2. Public Workshops will serve as a forum for communication between FDA and all audiences with an interest in the development of active medical product surveillance.  (January 12, 2011 Public Workshop )
3. Medical Product Surveillance Roundtables will provide an efficient mechanism for convening groups of stakeholders to share information, discuss events in the field of safety science, and explore focused questions.
4. Active Surveillance Implementation Meetings will serve to bridge the discussions described above into implementation of active surveillance pilot programs, while assuring neutrality and transparency.

Other Active Surveillance Projects of Interest

• Observational Medical Outcomes Partnership (OMOP) is a public-private partnership funded and managed through the Foundation for the National Institutes of Health that consists of a two year research program to advance the science of active medical product safety surveillance using existing observational databases.  OMOP will achieve this goal by systematically and empirically studying critical methodologic and data architecture and governance likely to be needed to establish a national medical product safety surveillance system using observational data.  The OMOP program is unique in several ways including its empirical approach to addressing key questions, its constituted governance structure, and the transparency of both processes and outputs.  OMOP promotes transparency by placing all information of interest in the public domain as quickly as possible.  OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the Food and Drug Administration (FDA), and other federal agencies.