CERT Coordinating Center

描述(由申请人提供)：本提案支持由RFA HS-07-0008下的凯撒永久健康研究中心(TCHR)提出的申请，作为由医疗研究和质量机构(AHRQ)赞助的教育和治疗研究中心(CERT)计划(U18)的协调中心(CC)。CERT是一项国家示范计划，开展研究和教育计划，促进药物、生物制品和医疗器械的最佳使用。CERTs计划是由11个研究中心组成的网络，每个研究中心都专注于一个广泛的治疗主题。总体而言，主题代表了关于新旧治疗剂的风险、益处和相互作用的有限比较信息的领域。CERT打算在发现、测试、营销、处方、消费和评估疗法的过程中将所有利益相关者聚集在一起。从证据驱动的、大写的、以人口为基础的医学的组织背景下工作，KP提供了一种重要的政策平衡，以服务收费的学术医学。CERT的研究议程显然也集中在翻译科学上。我们将利用我们作为临床和翻译科学奖中心和众多研究网络成员的地位，在全国各地的研究人员之间建立重要的关系。这项提案是由Kaiser Permanente(一家国际知名的非营利性综合医疗保健提供系统和CERTs合作伙伴)、俄勒冈健康与科学大学(主要的学术生物医学研究和健康中心，以及与TCHR合作的NIH临床和翻译科学奖首批12项之一)、AHRQ、食品和药物管理局(FDA)以及CERTs指导委员会(SC)组成的公私联合体，以支持CERTS的第三个研究和教育项目。鉴于CERTS SC是主要的决策机构，而CC的作用是支持和加强SC在研究、教育和筹资方面的职能和CERT之间的协调，我们建议的CC的具体目标有四个：1)提供从杜克大学医学中心以前的CERT CC到TCHR CERT CC的无缝过渡，以确保所有正在进行和计划中的SC倡议和CERT研究和教育活动不会受到不利影响；2)为CERTS SC提供基础设施和领导支持，以履行开展研究和提供教育的总体使命，以促进药物、医疗器械和生物制品的最佳使用；3)为下一个四年资金周期制定CERTS战略计划和战术优先事项；以及4)对CERT计划进行评估，以确定战略目标的实现程度、这些成功的影响以及遇到和克服的障碍。

DESCRIPTION (Provided by the Applicant): This proposal supports the application from The Center for Health Research (TCHR), Kaiser Permanente under RFA HS-07-0008 to serve as the Coordinating Center (CC) for the Centers for Education and Research on Therapeutics (CERTs) Program (U18) sponsored by the Agency for Healthcare Research and Quality (AHRQ). The CERTs are a national demonstration program conducting research and education programs that advance the optimal use of drugs, biologicals, and medical devices. The CERTs program is organized as a network of 11 research centers, each focusing on a broad therapeutic theme. In general, themes represent areas where limited comparative information exists on the risks, benefits, and interactions of newer and older therapeutic agents. The CERTs intend to bring together all the stakeholders in the process of discovering, testing, marketing, prescribing, consuming, and evaluating therapeutics. Working from the organizational context of evidence-driven, capitated, population-based medicine, KP offers an important policy counterbalance to fee-for-service academic medicine. The CERTs' research agenda is also clearly focused on translational science. We will leverage our position as a Clinical and Translational Science Awards center and a member of numerous research networks to establish important relationships among researchers across the country. This proposal represents a private-public consortium among Kaiser Permanente (an internationally renowned, non-profit, integrated healthcare delivery system and CERTs partner), the Oregon Health & Science University (a major academic biomedical research and health center, as well as, in partnership with TCHR, one of the first 12 NIH Clinical and Translational Science Awards), the AHRQ, the Food and Drug Administration (FDA), and the CERTs Steering Committee (SC) to support the third cycle of the CERTs' research and educational programs. Given that the CERTs SC is the primary decision-making body, and the CC's role is to support and enhance the SC's functioning and coordination among the CERTs with respect to research, education, and fund-raising, the specific aims of our proposed CC are four-fold: 1) Provide a seamless transition from the previous CERTs CC at Duke University Medical Center to the TCHR CERTs CC to ensure that all ongoing and planned SC initiatives and CERTs research and educational activities are not adversely affected; 2) Provide infrastructure and leadership support to the CERTs SC in carrying out the overall mission of conducting research and providing education that will advance the optimal use of drugs, medical devices, and biological products; 3) Develop the CERTs strategic plan and tactical priorities for the next 4-year funding cycle; and 4) Conduct evaluations of the CERTs program to identify the extent to which the strategic goals have been attained, the implications of these successes, and barriers encountered and overcome.