OSU Center of Excellence in Regulatory Tobacco Science (OSU-CERTS)

描述（由申请人提供）：俄亥俄州立大学烟草科学监管卓越中心（OSU-CERTS）的总体愿景是成为提供相关科学数据以支持FDA烟草制品中心监管决策的国家领导者。OSU-CERTS的总体主题是了解烟草产品偏好的潜在原因，特别是双重和多种用途，以及这些原因如何影响烟草产品类型不断变化的环境中的使用。该中心将把这一主题整合到在自然环境中进行的一系列青少年和成人队列研究中，辅以控制良好的实验研究，允许因果推理，OSU-CERTS包括具有共享队列，理论和/或措施的项目；所有项目都将提供城市和农村环境的数据，以提高普遍性。其中包括四个项目，全部采用相同的方法抽样（基于地址的抽样），其中一些家庭将由伙伴项目共享，其他家庭将用于其他项目。伙伴项目1和2将利用一个为期三年的青少年及其家庭队列，比较和确定吸烟、性传播工具使用和双重使用的流行程度，以及烟草使用的风险因素，重点是环境、广告和营销以及经常使用的轨迹。这项队列研究将包括致癌物质暴露的评估，以及味觉和烟草使用行为的遗传学。项目3将建立一个为期3年的成人队列，以描述长期使用烟草产品类型的多样性，并检查个人、认知和情感风险因素。它将考虑零售环境中的购买因素和营销实践。项目4将是几个实验研究，检查心理结构和选择烟草产品的决策模型。OSU-CERTS包括五个核心（A-E），为所有项目提供资源。核心包括：1)行政（核心A）；2)招聘、调查和保留（核心B）；3)生物统计学和数据资源（核心C）；4)发展和试点研究（核心D）；5)研究培训和教育（核心E）。OSU-CERTS基础设施和核心将为当前和未来的科学发现奠定基础，这将有助于FDA。目前，FDA在2012年1月提出了56项研究重点中的11项。机构承诺包括招聘新教师、资助初级教师、博士后研究员和试点项目。OSU-CERTS是一项培训下一代科学家和政策专家、资助创新试点项目和建立相关团队的投资。

DESCRIPTION (provided by applicant): The overall vision of The Ohio State University Center of Excellence in Regulatory Tobacco Science (OSU-CERTS) is to serve as a national leader in providing relevant scientific data to support FDA regulatory decision making in the Center for Tobacco Products. The overall theme of OSU-CERTS is to understand the reasons for underlying tobacco-product preferences, especially dual and poly-use, and how these reasons influence use in an environment of ever-changing diverse types of tobacco products. The Center will integrate this theme in a series of adolescent and adult cohort studies conducted in natural settings, complemented by well-controlled experimental studies that allow for causal inference, the OSU-CERTS includes projects with shared cohorts, theory, and/or measures; all projects will provide data for urban and rural settings to enhance generalizability. Included are four projects, all sampled from the same methodology (address based sampling), where some households will be shared by companion projects and other households will be used for other projects. Companion Projects 1 and 2 will utilize a three year cohort of adolescents and their families to compare and establish the prevalence of smoking, ST use and dual use, and tobacco-use risk factors with an emphasis on environment, advertising and marketing, and trajectories to regular use. This cohort study will include an assessment of carcinogen exposure, and genetics for taste perception and tobacco use behavior. Project 3 will establish a 3 year cohort of adults to characterize the diversity of types of tobacco products used overtime and examine individual, cognitive and affective risk factors. It will consider purchasing factors and marketing practices in retail environments. Project 4 will be several experimental studies that examine psychological constructs and decision making models for choosing tobacco products. The OSU-CERTS includes five cores (A-E) to provide resources to all projects. Cores include: 1) Administrative (Core A); 2) Recruitment, Survey and Retention (Core B); 3) Biostatistics and Data Resources (Core C); 4) Developmental and Pilot Research (Core D); and 5) Research Training and Education (Core E). The OSU-CERTS infrastructure and cores will set the foundation for current and future scientific discoveries that will assist th FDA. It currently addresses 11 of 56 research priorities set forth by the FDA in January, 2012. Institutional commitment includes recruitment of new faculty and funding for junior faculty, postdoctoral fellows and pilot projects. OSU-CERTS is an investment that trains the next generation of scientists and policy experts, funds innovative pilot projects and establishes relevant cohorts. RELEVANCE: OSU-CERTS will assist to improve public health and reduce population harm from tobacco product use. Harm involves individual disease risk and prevalence of product use. OSU-CERTS will conduct a series of projects to provide information about the relationships between ever-changing diverse types of tobacco product use among rural (Appalachian OH) and urban (Columbus OH) adolescents and adults at risk for tobacco-attributable disease and death. This information assists the FDA to regulate harmful products.