The Center Education and Research on Therapeutics (CERTs) Scientific Forum

描述(由申请者提供)：教育和治疗研究中心(CERT)研究和示范计划是一项全国性的倡议，由医疗研究和质量机构(AHRQ)与美国食品和药物管理局(FDA)协商，作为合作协议运行。CERTS汇集了致力于治疗的安全性和有效性的领先科学家，以合作进行研究，解决持续不断的生物医学研究进展所产生的监管科学问题，以及对患者安全和健康结果的挑战。自1999年以来，CETS一直在进行研究并提供教育，以促进药物、医疗器械和生物制品的最佳使用。CERTS试图解释美国医疗保健面临的许多问题，包括衡量医疗质量、制定循证指南、为药物和设备批准开发证据基础、比较有效性研究和传播活动等。我们作为CERTS协调中心(CC)的四年经验使我们对这一独特努力的使命、愿景和价值有了独特的视角和深刻的理解。这项成为CERTS科学论坛(CS论坛)的建议借鉴了我们对CERTS计划的经验和理解，我们认识到CS论坛代表着对前CC活动的实质性扩展。 作为CS论坛，我们将：1)促进和支持五个优先领域的合作研究和翻译活动：比较有效性；患者安全；开发/增强和验证“工具”；医疗保健系统干预；以及转化为实践或政策；2)支持CERT指导委员会；以及3)作为CERT的交流和翻译中心。我们的研究团队由九名科学家组成，他们具有互补的技能组合，旨在涵盖CERT的所有五个研究优先领域。我们还开发了目前的CERT安全和公共网站，并确保其持续维护。作为FDA微型哨兵网络的数据持有者，我们也处于有利地位，能够全面参与这些合作，我们在医疗保健提供系统中的地位使我们能够了解如何将CERT的结果转化为实践。此外，作为Kaiser Permanente Northwest和贝勒医学院(BCM)之间的合作伙伴关系，我们可以专门利用BCM教职员工和与艾森伯格中心相关的工作人员的传播专业知识来准备翻译和传播策略，以便将CERT证据提供给处于或接近CAPP点的决策者。 与公共健康相关：CERTs计划汇集了许多进行药物和设备研究的中心。作为该计划的科学论坛，我们将为这些中心的研究计划注入活力，支持CERT指导委员会的工作，并帮助传播该计划的发现。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.