Safety
FDA's Sentinel Initiative - Deliverables from Completed Contracts
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 the Initiative's various components. The work posted in this area updates those interested in the Sentinel Initiative on specific projects and enables 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 editing. Those parties interested in obtaining the report appendices can request them using the Freedom of Information Act (FOIA) procedures.
You can join FDA’s listserv and receive notifications on updates.
Project Report: Evaluation of Potential Data Sources for the Sentinel Initiative
This project's scope of work consists of identifying, describing, and evaluating potential data sources and/or data environments that could participate in the Sentinel Initiative. This project involves conducting a thorough analysis of each data source's: (1) utility for post-market surveillance of FDA-regulated drugs, biologics (excluding blood and tissue products), and devices; (2) scope, content, structure, quality, and timeliness of data; (3) patient population(s), duration of follow-up and capture of care across all settings; (4) availability, experience and interest of investigators with knowledge of the data in using it for post-market product safety surveillance as well as plans for further data source enhancements; (5) availability, experience and interest of investigators with knowledge of the data in participating in a distributed data network; and (6) potential privacy and security concerns related to the use of electronic health data; (7) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising data sources and/or environments as the Sentinel Initiative moves forward.
This project's scope of work is to identify, describe, and evaluate existing signal detection methods that could be employed in the Sentinel Initiative. The 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 identify appropriately the absence of important safety signals; (4) ability to minimize both false-positive and false-negative safety signals; (5) the methodology's robustness in performing across different types of data systems to detect different types of safety signals; (6) the methodology's flexibility in adapting 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 on applying the most promising signal detection methodologies as the Sentinel Initiative advances.
Project Report: Engagement of Patients, Consumers, and Healthcare Professionals in the Sentinel Initiative
This project's scope of work is to perform the research and analysis necessary to identify successful approaches for engaging patients, consumers, and healthcare professionals in the early stages of Sentinel System development. This project required a thorough analysis of patient, consumer, and physician (and other healthcare professional) perspectives related to (1) the importance of postmarket surveillance, (2) the FDA’s use of electronic health data in postmarket surveillance, (3) privacy and security concerns related to the use of electronic health data, and (4) their possible role in creating and implementing the Sentinel System. The project also required analyzing federal--and to the extent possible-- local regulations related to maintaining the privacy and security safeguards necessary when using electronic health data. Finally, these analyses should lead to identifying specific recommendations for further involvement of this important stakeholder group as the Sentinel Initiative advances. Please note, this project resulted in three deliverables, a report on engaging patients and consumers, a report on engaging health care professionals, and an analysis of legal issues related to structuring FDA Sentinel Initiative Activities.
This project's scope of work is to identify, describe, and evaluate potential U.S. orthopedic implant registries that could participate in the creation of a national network of such registries as part of the Sentinel Initiative. The implants of interest would include, but are not limited to, total hip, total knee, hip resurfacing, intervertebral disk implants, and ankle devices. This project required a thorough analysis of each registry’s: (1) scope, content, structure, quality, and timeliness of data; (2) patient population(s), duration of follow-up and capture of care across all settings; (3) plans for further registry enhancements; (4) availability, experience and interest of investigators with knowledge of the data in using them for surveillance of post-market product performance; (5) availability, experience and interest of investigators with knowledge of the data in participating in a distributed data network; (6) potential privacy and security concerns related to the use of electronic health data; (7) view of working with professional societies in creating a distributed network; and (8) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising data sources and/or environments as the Sentinel Initiative advances. It should also include a value proposition and engagement strategy for registry owners and professional societies.
This project's scope of work is to define and critically evaluate possible database models that should be considered for use in the Sentinel Initiative as it evolves to enhance the the system's performance and findings. As currently envisioned, the Sentinel System will enable FDA to capitalize on the capabilities of multiple, existing automated healthcare data systems to augment the Agency’s current surveillance capabilities. The System will enable queries of distributed data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations that agree to participate in this system will be included. Operations will adhere to strict privacy and security safeguards. Although the distributed model described above is how the Agency foresees the initial implementation of the Sentinel Initiative, we realize that other models exist that should be explored and understood for their eventual contribution to the Initiative.
Project Report: Developing a Governance and Operations Structure for the Sentinel Initiative
This project's scope of work is to identify and analyze governance and operating structures to be considered for implementing the Sentinel Initiative, to include existing public-private partnerships that may be relevant. Additionally, the project involved outlining recommendations for next steps related to implementation and moving Sentinel into an operational phase. Work includes investigating strategies for involving all stakeholder groups in the Sentinel Initiative and optimizing the value for all through the development of the Initiative.
Project Report: Evaluation of Timeliness of Medical Update for Surveillance in Health Care Databases
This project's scope of work includes examining two recent medical product launches, each in at least two different types of healthcare databases, which could participate in the Sentinel Initiative to assess the timeliness of uptake of these products by patients in each database. The project will require a thorough analysis of two medical products launched within the past several years in at least two different healthcare databases for: (1) the number of patients identified as using each medical product each month in each healthcare database throughout the first year after launch; (2) a description of the patients using the product, and characteristics of that use (e.g., product strength, days supply and overall duration of use); (3) the time elapsed before 1 patient, 100 patients, 1000 patients, 10,000 patients and 100,000 patients could be identified in each database using these products; (4) identifying factors that influence the uptake of new medical products in each of the databases examined. These analyses will be interpreted in the context of the population included and represented by the healthcare database to determine the degree to which the findings can be generalized to the nation as a whole. These analyses should lead to recommendations for important characteristics or minimum criteria relating to medical product uptake that could be considered when evaluating healthcare data systems for inclusion as the Sentinel Initiative advances.
This project's scope of work is to identify and evaluate population-based data sources that could be used to study the safety of blood and tissue products. This project required a thorough analysis of each data source’s: (1) utility for post-market surveillance of FDA-regulated blood and tissue products (2) scope, content, structure, quality, and timeliness of data; (3) patient population(s), duration of follow-up, and capture of care across all settings; (4) availability, experience, and interest of investigators with knowledge of the data in using it for blood and tissue product safety surveillance as well as plans for further data source enhancements; (5) availability, experience, and interest of investigators with knowledge of the data in participating in a distributed data network; (6) potential privacy and security concerns related to the use of electronic health data; and (7) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific evaluations of the feasibility to conduct safety related studies for blood and tissue products in each data source
Project Report: Evaluation of State Privacy Regulations in Relation to the Sentinel Initiative
This project's scope of work involves conducting a legal evaluation of state statues, regulations and practices in each of the 50 states in order to determine whether data sources may participate in the Sentinel Initiative and the conditions on that participation. It is noted that Federal regulations, including the HIPAA Privacy Rule constitutes a minimum for privacy protection, so states may enact more rigorous privacy protection if desired. This project encompasses a thorough evaluation of state statues and regulations to determine whether those state laws impose any additional restrictions on the use or disclosure of health information beyond the federal law requirements discussed in the legal analysis already received by the Agency, and if so, to set out what those additional restrictions entail.
Project Report: Evaluation of Potential Data Sources for Animal Drugs Used in Veterinary Medicine
This project's scope of work is the identification, description, and evaluation of potential data sources and/or data environments that could participate in the Sentinel Initiative to assist in the understanding of drug safety issues as they manifest animals. This project involved conducting a thorough analysis of each data source's: (1) utility for post-market surveillance of FDA-regulated drugs; (2) scope, content, structure, quality, and timeliness of data; (3) availability, experience and interest of investigators with knowledge of the data in using it for post-marketing product safety surveillance as well as plans for further data source enhancements; (4) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising data sources and/or environments for understanding drug safety issues in animals as the Sentinel Initiative moves forward.
