Center for the Study of Tobacco Products

烟草制品研究中心

• 批准号: 8915111
• 负责人: THOMAS EVAN EISSENBERG
• 金额: $ 382.63万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8915111
• 关键词: Acute; Address; Adverse event; Advisory Committees; Attitude; Behavior; Belief; Biological Markers; Cigarette; Cigarette Smoker; Cognition; Communication; Data; Data Sources; Discipline; Drug abuse; Electronic cigarette; Ensure; Environment; Evaluation; Family; Funding; Goals; Grant; Human; Lead; Learning; Long-Term Effects; Marketing; Measures; Methods; Modeling; Nicotine; Oral; Oxidative Stress; Policies; Principal Investigator; Process; Public Health; Qualitative Methods; Randomized Controlled Trials; Regulation; Research; Research Infrastructure; Research Project Grants; Respiratory physiology; Risk; Science; Scientist; Smoking Prevention; Structure; Technology; Tobacco; Tobacco smoke; Toxicant exposure; Training and Education; United States Food and Drug Administration; United States National Institutes of Health; Virginia; data management; design; disorder risk; flexibility; hookah; innovation; learned behavior; mathematical model; meetings; member; novel; pre-doctoral; programs; success; tobacco control; tool; toxicant; vapor

DESCRIPTION (provided by applicant): The U.S. tobacco marketplace is changing fast, and regulatory science lags far behind. The FDA can alter this dynamic, but needs the tools to do so. One necessary tool is a model for evaluating all types of "modified risk tobacco products" (MRTPs): novel tobacco products marketed with the claim that they reduce harm or risk associated with conventional products. There are few demonstrated models for predicting tobacco product harm or risk, which demands an understanding of MRTP constituents using analytic lab methods, toxicant exposure and abuse liability using human lab methods, longer-term effects using randomized control trial (RCT) methods, and attitudes, beliefs, and perceived effects using quantitative and qualitative methods. The overarching goal of the Center for the Study of Tobacco Products is to demonstrate empirically an integrated, iterative MRTP evaluation model that uses all of these methods to inform tobacco product regulation across all product types (combustible, oral, or vapor). The Center unites NIH-funded scientist/educators from multiple disciplines to demonstrate the transdisciplinary MRTP evaluation model. We begin with an evaluation of "electronic cigarettes" (EClGs), novel tobacco products that are marketed now and increasingly popular. EClGs offer an opportunity to demonstrate how the model we propose can inform regulatory policy. To meet the Center's overarching goal we describe four integrated, multi-year projects that aim to: 1) Examine factors that influence MRTP nicotine and toxicant yield; 2) Compare short-term effects of MRTPs to other products in the human lab; 3) Characterize effects of real-world MRTP use in the natural environment using RCT methods; and 4) Study the influence MRTP use and misuse on user attitudes, beliefs, and perceived effects using qualitative and quantitative methods. An Administrative Core will facilitate financia and managerial processes, provide data management and biostatistical support, co-ordinate communication within and across centers, and interface with scientists and policymakers. A Training and Education Core will develop a course on transdisciplinary methods for evaluating products and will support up to 4 pre-doctoral and 4 postdoctoral appointees. Finally, a pilot research program will solicit and fund innovative projects from our Virginia-wide network of scientists and respond to emerging products of any type. The Center is thus structured to address FDA needs and operate collaboratively. Overall, this Center will provide the expertise, innovation, infrastructure, and information necessary for the sustained success of FDA's mandate to regulate novel tobacco products, including MRTPs. RELEVANCE: This Center is designed to inform tobacco regulatory science and thereby contribute to public health. The four projects will answer important questions about electronic cigarettes while giving the Food and Drug Administration an empirical demonstration of a transdisciplinary, integrated, iterative, MRTP evaluation model. The Center thus provides FDA necessary scientific tools to ensure that only those novel tobacco products that have positive public health effects are marketed.

描述（由申请人提供）：美国烟草市场正在迅速变化，监管科学落后于远方。 FDA可以改变这种动态，但需要工具才能这样做。一种必要的工具是一个模型，用于评估所有类型的“改良风险烟草产品”（MRTPS）：新型烟草产品的销售，并说它们减少了与常规产品相关的危害或风险。很少有用于预测烟草产品危害或风险的模型，该模型需要使用分析实验室方法，使用人类实验室方法，使用随机对照试验（RCT）方法（RCT）方法以及使用定量和定性方法来理解MRTP成分，使用人类实验室方法，使用随机对照试验（RCT）方法以及态度，信念和感知效应。烟草产品研究中心的总体目标是在经验上证明一种综合的，迭代的MRTP评估模型，该模型使用所有这些方法来告知所有产品类型（可燃烧，口服，或蒸气）的烟草产品调节。该中心将来自多个学科的NIH资助的科学家/教育者团结起来，以展示跨学科的MRTP评估模型。我们首先要评估“电子烟”（ECLGS），这是现在销售且越来越受欢迎的新型烟草产品。 ECLG提供了一个机会来展示我们建议的模型如何为监管政策提供信息。为了满足该中心的总体目标，我们描述了四个综合的多年项目，目的是：1）研究影响MRTP尼古丁和毒性产量的因素； 2）将MRTP与人类实验室中其他产品的短期影响进行比较； 3）表征了使用RCT方法在自然环境中使用现实世界中MRTP的影响； 4）研究MRTP使用和滥用对用户态度，信念和使用定性和定量方法的影响的影响。行政核心将促进金融和管理流程，提供数据管理和生物统计支持，在中心内外的协调沟通，以及与科学家和政策制定者的互动。培训和教育核心将开发有关评估产品的跨学科方法的课程，并将支持多达4个博士后和4个博士后任命。最后，一项试点研究计划将从我们整个弗吉尼亚州的科学家网络中征集和资助创新项目，并响应任何类型的新兴产品。因此，该中心的结构是满足FDA需求并进行协作运作。总体而言，该中心将提供专业知识，创新，基础架构以及FDA命令持续成功以调节包括MRTP在内的新型烟草产品所必需的信息。 相关性：该中心旨在告知烟草监管科学，从而为公共卫生做出贡献。这四个项目将回答有关电子卷烟的重要问题，同时为食品药物管理局提供了跨学科，综合，迭代，MRTP评估模型的经验证明。因此，该中心提供了FDA必要的科学工具，以确保只有那些具有积极公共卫生影响的新型烟草产品才能销售。