The Centers for Education and Research on Therapeutics (CERTs) research and demonstration program is a national initiative run as a cooperative agreement by the Agency for Healthcare Research and Quality (AHRQ), in consultation with the U.S. Food and Drug Administration (FDA). CERTs gathers leading scientists working on the safety and effectiveness of therapeutics to collaborate on research addressing issues in regulatory science arising from the continuous stream of biomedical research advances as well as challenges to patient safety and health outcomes. CERTs has been conducting research and providing education that advanced the optimal use of drugs, medical devices, and biological products since 1999. CERTs seeks to explicate many of the issues facing US healthcare, including measuring care quality, developing evidence-based guidelines, developing an evidence base for drug and device approvals, comparative effectiveness research, and dissemination activities, among others. Our four years of experience as the CERTs Coordinating Center (CC) has given us a unique perspective and deep understanding of the mission, vision, and values of this unique endeavor. This proposal to be the CERTs Scientific Forum (CS Forum) draws on our experience and understanding of the CERTs program, and we recognize that the CS Forum represents a substantial expansion beyond the activities of the former CC. As the CS Forum, we will: 1) catalyze and support collaborative research and translational activities in the five priority areas: comparative effectiveness;patient safety;development/enhancement and validation of """"""""tools"""""""";health care system interventions;and translation into practice or policy;2) support the CERTs Steering Committee;and, 3) serve as the CERTs communications and translation hub. Our investigator team comprises nine scientists with complementary skill mixes designed to cover all five of the CERTs research priority areas. We also developed the current CERTs secure and public websites and ensure their ongoing maintenance. As a data holder in the FDA's mini-sentinel network, we are also well-positioned to fully participate in these collaborations and our position within a health care delivery system enables us to understand how to translate the CERTs findings into practice. Moreover as a partnership between Kaiser Permanente Northwest and Baylor College of Medicine (BCM), we can draw specifically on communications expertise of the BCM faculty and staff associated with the Eisenberg Center to prepare translation and dissemination strategies to get CERTs evidence into the hands of decision makers at or close to the point of carp.
The CERTs program draws together many centers conducting research on drugs and devices. As the Scientific Forum for this program, we will energize these centers'research programs, support the work of the CERTs steering committee, and help disseminate the program's findings.
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