Center for the Study of Tobacco Products

描述（由申请人提供）：美国烟草市场正在快速变化，而监管科学却远远落后。 FDA 可以改变这种动态，但需要工具来做到这一点。一个必要的工具是评估所有类型的“降低风险烟草产品”（MRTP）的模型：销售的新型烟草产品声称可以减少与传统产品相关的危害或风险。用于预测烟草产品危害或风险的模型很少，这需要使用分析实验室方法了解 MRTP 成分，使用人体实验室方法了解有毒物质暴露和滥用责任，使用随机对照试验 (RCT) 方法了解长期影响，以及使用定量和定性方法了解态度、信念和感知效果。烟草制品研究中心的总体目标是凭经验证明一个综合的、迭代的 MRTP 评估模型，该模型使用所有这些方法来为所有产品类型（可燃、口服或蒸气）的烟草制品监管提供信息。该中心联合 NIH 资助的来自多个学科的科学家/教育工作者来展示跨学科的 MRTP 评估模型。我们首先对“电子烟”（EClG）进行评估，这是一种现已上市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提出的模型如何为监管政策提供信息。为了实现该中心的总体目标，我们描述了四个综合的多年期项目，旨在： 1) 检查影响 MRTP 尼古丁和毒物产量的因素； 2) 在人体实验室中比较 MRTP 与其他产品的短期效果； 3) 使用 RCT 方法表征真实世界 MRTP 在自然环境中使用的效果； 4) 使用定性和定量方法研究 MRTP 使用和误用对用户态度、信念和感知效果的影响。行政核心将促进财务和管理流程，提供数据管理和生物统计支持，协调中心内部和中心之间的沟通，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一门关于评估产品的跨学科方法的课程，并将支持最多 4 名博士前和 4 名博士后任命。最后，试点研究计划将从我们弗吉尼亚州范围内的科学家网络中征求和资助创新项目，并对任何类型的新兴产品做出反应。因此，该中心的结构是为了满足 FDA 的需求并协作运作。总体而言，该中心将提供必要的专业知识、创新、基础设施和信息，以确保 FDA 监管新型烟草产品（包括 MRTP）的任务取得持续成功。 相关性：该中心旨在为烟草监管科学提供信息，从而为公共卫生做出贡献。这四个项目将回答有关电子烟的重要问题，同时为食品和药物管理局提供跨学科、综合、迭代的 MRTP 评估模型的实证演示。因此，该中心为 FDA 提供了必要的科学工具，以确保只有那些对公共健康有积极影响的新型烟草产品才能上市。

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.