Improved Models to Inform Tobacco Product Regulation

描述(由申请人提供)：烟草监管科学中心的主要主题是开发改进的模型，为烟草产品监管战略提供信息，其中包括1)烟草使用对健康成本的经济影响，2)风险认知，感知可接受性，消费者对支持烟草营销和反烟草信息的反应，以及其他烟草使用的社会决定因素，以及3)由于烟草使用和二手烟暴露而导致的风险的快速变化，表现为心血管和肺功能障碍。TCORS包括五个完整的项目(一个关于经济模型，两个关于行为模型，两个关于心血管和肺部疾病模型)，两个发展项目(一个关于行为模型，一个关于心血管和肺部疾病模型)，三个核心(行政，信息学和分析，以及生物标记)，一个博士后培训计划和一个选择未来发展项目的过程。研究结果将为FDA对烟草制品的制造、分销和营销提供改进的科学框架，以评估特定监管战略的可能效果，方法是：1)改进经济模型，用于分析烟草使用的短期和长期影响拟议的法规；2)更好地理解烟草使用的行为和社会决定因素(包括对风险的感知和决策过程)，为经济模型、营销监管和公众教育提供信息；3)对烟草使用和二手烟的急性心肺反应的功能生物标记物，它们可能预测未来的疾病，并支持改进的经济模型的开发。特别是，这些改进的经济模型将纳入由于心血管和肺部疾病减少而导致的风险的快速变化，预计FDA的监管决定将导致这些变化。该TCORS建立在加州大学旧金山分校烟草控制研究和教育中心强大的跨学科和协作研究、教育和服务的传统之上。 相关性：这份TCORS将通过开发新的经济模型来解释烟草使用的短期和长期影响，更好地了解烟草使用的行为决定因素，并确定可用于烟草产品上市前测试的烟草使用急性心肺反应的功能性生物标记物，为FDA的监管提供信息。

DESCRIPTION (provided by applicant): The overarching theme of this Tobacco Center of Regulatory Science is the development of improved models to inform tobacco product regulatory strategies that integrate 1) economic impacts of tobacco use on health costs, 2) risk perceptions, perceived acceptability, consumer responses to pro-tobacco marketing and anti-tobacco messages and other social determinants of tobacco use, and 3) rapid changes in risk due to tobacco use and secondhand smoke exposure as manifested in cardiovascular and pulmonary dysfunction. This TCORS includes five full projects (one on economic models, two on behavioral models, and two on cardiovascular and pulmonary disease models), two developmental projects (one on behavioral models and one on cardiovascular and pulmonary disease models), three Cores (Administrative, Informatics and Analysis, and Biomarker), a postdoctoral training program and a process for selecting future developmental projects. The results will inform FDA regulation of the manufacture, distribution and marketing of tobacco products by providing an improved scientific framework in which to evaluate the likely effects of specific regulatory strategies by developing 1) improved economic models for analysis of proposed regulations that account for short-term as well as long-term effects of tobacco use, 2) better understanding of behavioral and social determinants of tobacco use (including perception of risk and decision making processes) to inform the economic models, regulation of marketing, and public education about risks of tobacco products, and 3) functional biomarkers of acute cardiopulmonary responses to tobacco use and secondhand smoke that may predict future disease and also support development of improved economic models. In particular, these improved economic models will integrate the rapid changes in risk due to reductions in cardiovascular and pulmonary diseases which would be expected to result from FDA regulatory decisions. This TCORS is built on the UCSF Center for Tobacco Control Research and Education's tradition of strong transdisciplinary and collaborative research, education and service. RELEVANCE: This TCORS will inform FDA regulation by developing new economic models that account for short-term and long-term effects of tobacco use, developing a better understanding of behavioral determinants of tobacco use, and identifying functional biomarkers of acute cardiopulmonary responses to tobacco use that could be used in premarket testing of tobacco products.