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As part of FDA’s commitment to making the Sentinel Initiative a transparent process, this Web page is dedicated to sharing completed work from contracts granted to inform various aspects of the Initiative. The work posted in this area is meant to update those interested in the Sentinel Initiative on specific projects and to enable contributions from interested parties.
Completed work from contracts is being made available for comment in FDA's docket number FDA-2009-N-0192. A link will be provided to each document as it is received and made available in the docket. Report appendices will not be posted to avoid delays that would ensue due to review and redaction. Those parties interested in obtaining the report appendices will need to request them using the Freedom of Information Act (FOIA) procedures.
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Project Report: Evaluation of Existing Methods for Safety Signal Identification for the Sentinel Initiative
The scope of work of this specific project is the identification, description, and evaluation of existing signal detection methods that could be employed in the Sentinel Initiative. This project asked for a thorough analysis of each methodology’s: (1) utility for postmarket surveillance of FDA-regulated drugs, biologics, and devices; (2) sensitivity, or ability to appropriately identify important safety signals; (3) specificity, or ability to appropriately identify the absence of important safety signals; (4) ability to minimize both false-positive and false-negative safety signals; (5) robustness of the methodology to perform across different types of data systems for detection of different types of safety signals; (6) flexibility of the methodology to adapt to different situations and to change thresholds for different safety issues as desired and; (7) barriers that exist to using each identified methodology in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising signal detection methodologies as the Sentinel Initiative moves forward.
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