Models For Tobacco Product Evaluation

烟草产品评估模型

• 批准号: 8269398
• 负责人: DOROTHY K HATSUKAMI
• 金额: $ 265.24万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8269398
• 关键词: Address; Affect; Age; Animals; Area; Biological Markers; Biometry; Carcinogens; Characteristics; Cigarette Smoker; Clinical Trials; Clinical Trials Design; Collaborations; Complex; Congresses; Contracts; Data; Data Analyses; Databases; Decision Making; Dependence; Development; Drug Formulations; Elements; Ethnic Origin; Evaluation; Exposure to; Family; General Population; Goals; Grant; Guidelines; Harm Reduction; Health; Human; Individual; Informatics; Instruction; Knowledge; Laws; Lead; Marketing; Measures; Methods; Modeling; National Cancer Institute; Nature; Oral; Oral Tobacco; Outcome; Perception; Performance; Policies; Population; Process; Program Research Project Grants; Public Health; Race; Regulation; Relative (related person); Research; Research Design; Review Literature; Risk; Risk Assessment; Sampling; Science; Scientist; Series; Shapes; Smoker; Smoking Prevention; Testing; Time; Tobacco; Toxic effect; Toxicant exposure; Translating; United States Food and Drug Administration; Validity and Reliability; authority; base; biobank; disorder risk; economic behavior; empowered; experience; innovation; population health; response; sex; snus; sound; tobacco control; tool; toxicant; uptake

DESCRIPTION (provided by applicant): In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTCA) which gave the Food and Drug Administration (FDA) regulatory authority over tobacco products. Under this law the FDA is required to evaluate new and modified tobacco products for their effects on a population wide-basis. Yet, there is limited knowledge on the measures and methods that should be used to evaluate these products. What is needed now are reliable and valid measures and methods that regulators can use to predict in advance how consumers are likely to respond (i.e., use leading to exposure) to new and modified tobacco products. This P01 builds on our previous NCI contract [N01PC644202], which proposed a comprehensive framework for evaluating tobacco products. This P01 attempts to test elements of that framework by conducting a series of interrelated studies designed to assess the potential uptake and dependence of a new oral tobacco product and resulting toxicant exposure in current cigarette smokers. To date, no systematic and comprehensive studies have been conducted to validate methods and measures for tobacco product evaluation. Specifically, Projects 1 and 2 will evaluate methods and measures to assess the relative abuse liability of tobacco products in animals and in humans. Project 3 seeks to understand and assess various aspects of consumer perception of tobacco products, and Project 4 assesses tobacco product use and its effects on exposure to toxicants in the context of a clinical trial. In addition to these Projects, we have an Administrative Core (Core A ) responsible for supporting the administration of the grant, facilitating collaboration, assuring th quality and timeliness of our science, integrating the results from the Projects and translating our research findings into potential policies; a Tobacco Constituent and Biomarker Core (Core B) that will be responsible for providing constituent analysis and analyzing our samples for carcinogen biomarkers of exposure and effect, and establishing a biorepository; a Biostatistics and Informatics Core (Core C) responsible for database development and management, statistical analysis for each of the projects, and coordinating data analysis across projects. At the conclusion of this P01 we will have produced evidence on the reliability and validity of an array of methods and measures that can be applied to predict how consumers are likely to use and abuse new and modified tobacco products. The findings from this study should directly influence the kinds of methods and measures that FDA and other regulatory groups around the world might apply to evaluating harm reduction potential of new and modified tobacco products. Furthermore, because of the integrative nature of the studies, this P01 will help us understand how product characteristics, product abuse liability and consumer perception of a product and moderating influences (i.e., sex, age, race/ethnicity) affects uptake and use and resulting toxicant exposure.

描述（由申请人提供）：2009年，国会颁布了《预防家庭吸烟和烟草控制法》（FSPTCA），该法案赋予了食品药品监督管理局（FDA）对烟草产品的监管机构。根据该法律，FDA需要评估新的和改良的烟草产品对人口宽基础的影响。然而，关于评估这些产品的措施和方法的知识有限。现在需要的是可靠且有效的措施和方法，而监管机构可以用来预先预测消费者对新和经过修改的烟草产品的响应方式（即导致暴露）的响应方式。该P01建立在我们以前的NCI合同[N01PC644202]的基础上，该合同提出了一个评估烟草产品的综合框架。该P01试图通过进行一系列相互关联的研究来测试该框架的元素，旨在评估新的口服烟草产品的潜在摄取和依赖性，并导致当前吸烟者中的毒性暴露。迄今为止，尚未进行系统和全面的研究来验证烟草产品评估的方法和措施。具体而言，项目1和2将评估评估动物和人类烟草产品相对滥用责任的方法和措施。项目3旨在理解和评估消费者对烟草产品的各个方面，项目4评估烟草产品的使用及其对临床试验中对毒物暴露的影响。除这些项目外，我们还有一个行政核心（核心A）负责支持赠款的管理，促进协作，确保科学的质量和及时性，将项目的结果整合在一起，并将我们的研究发现转化为潜在的政策;烟草成分和生物标志物核心（核心B），将负责提供组成分析并分析我们的样品，以了解暴露和效果的致癌生物​​标志物，并建立生物措施；负责数据库开发和管理，每个项目的统计分析的生物统计学和信息学核心（核心C）以及跨项目的数据分析。在本P01的结论结束时，我们将为一系列方法和措施的可靠性和有效性提供证据，这些方法和措施可用于预测消费者如何使用和滥用新的和修改的烟草产品。这项研究的发现应直接影响FDA和世界各地其他监管组的方法和措施的种类和措施，以评估新的和改良的烟草产品的损害减少潜力。此外，由于研究的综合性质，该P01将有助于我们了解产品特征，产品滥用责任和消费者对产品的看法以及调节影响（即性别，年龄，种族/种族/种族）会影响吸收，使用和使用和结果有毒的暴露。