FDA Seeks Contractors for Sentinel System

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative.

Rockville, MD (Aug. 11)-The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency’s Sentinel Initiative. In a request for quotations (RFQ), FDA said the assignment requires a contractor to analyze the following qualities of each data source:

  • Utility for postmarket surveillance of FDA-regulated drugs, biologics, and devices

  • Scope, content, structure, quality, and timeliness of data

  • Patient populations, duration of follow-up, and capture of care across all settings

  • Availability, experience, and interest of investigators with knowledge of the data in using it for postmarket product-safety surveillance as well as plans for further data-source enhancements

  • Availability, experience, and interest of investigators with knowledge of the data in participating in a distributed data network

  • Potential privacy and security concerns related to the use of electronic-health data

  • Barriers to including each data source in the Sentinel Initiative.

FDA will expect the contractor to make specific recommendations about the most promising data sources and environments after it has completed its analysis.

The agency also issued an RFQ to find a contractor that would find and evaluate signal-detection methods to support the Sentinel Initiative. According to the document, the contractor will be asked to analyze methods according to the following criteria:

  • Sensitivity (i.e., ability to appropriately identify important safety signals)

  • Specificity (i.e., ability to appropriately identify the absence of important safety signals)

  • Ability to minimize false positive and false negative safety signals

  • Robustness of methodology to perform across different types of data systems to detect various types of safety signals

  • The methodology’s ability to adapt to different situations and to change thresholds for various safety issues as desired

  • Barriers to using each identified methodology in the Sentinel Initiative.

The Sentinel Initiative aims to create a national, electronic distributed network that improves FDA's ability to monitor drug products’ postmarket performance. As currently envisioned, the initiative will give the agency access to data sources such as electronic health-record systems, Medicare data, and medical-claims databases. The Sentinel Initiative will be created through a public–private partnership that includes government agencies, data holders, academia, patients, consumers, and healthcare professionals.

Quotations for both RFQs are due on Sept. 2, 2008. FDA plans to award contracts on Sept. 18, 2008.

For more about the Sentinel Initiative, see “FDA's Sentinel Initiative Will Improve Adverse-Event Tracking.”