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卓越中心(OSU-CERTS)的总体愿景是在为烟草产品中心的FDA监管决策提供相关科学数据方面处于全国领先地位。OSU-CERTS的总主题是了解烟草产品基本偏好的原因，特别是双重和多种用途，以及这些原因如何影响在不断变化的各种类型烟草产品的环境中的使用。该中心将把这一主题纳入在自然环境中进行的一系列青少年和成人队列研究，并辅之以能够进行因果推断的良好控制的实验研究，OSU-CERTS包括具有共同队列、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，以增强普适性。包括四个项目，都是从相同的方法(基于地址的抽样)中抽样的，其中一些家庭将由配套项目共用，其他家庭将用于其他项目。伙伴项目1和2将利用为期三年的青少年及其家庭队列，比较和确定吸烟的流行率、ST的使用和双重使用以及烟草使用的风险因素，重点是环境、广告和营销，以及常规使用的轨迹。这项队列研究将包括对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，以确定加班使用的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将是几项实验研究，考察选择烟草产品的心理结构和决策模型。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)生物统计和数据资源(核心C)；4)发展和试点研究(核心D)；以及5)研究培训和教育(核心E)。OSU-CERTS的基础设施和核心将为当前和未来的科学发现奠定基础，这些发现将有助于FDA。它目前解决了FDA在2012年1月提出的56项研究优先事项中的11项。机构承诺包括招聘新教师以及为初级教师、博士后研究员和试点项目提供资金。OSU-CERTS是一项投资，旨在培训下一代科学家和政策专家，为创新的试点项目提供资金，并建立相关的队列。 相关性：OSU-CERTS将帮助改善公众健康并减少烟草产品使用对人口的危害。危害包括个人疾病风险和产品使用的普遍性。OSU-CERTS将开展一系列项目，以提供关于农村(阿巴拉契亚，俄亥俄州)和城市(哥伦布，俄亥俄州)青少年和成人之间不断变化的不同类型烟草产品使用之间的关系的信息，这些青少年有可能患上烟草引起的疾病和死亡。这些信息有助于FDA对有害产品进行监管。

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.