Vermont Center on Tobacco Regulatory Science

描述(由申请者提供)：本申请的总体目标是建立佛蒙特州烟草监管科学中心(VCTRS)。这个多学科中心将设在佛蒙特州大学，但将与布朗大学、约翰·霍普金斯大学、明尼苏达大学和匹兹堡大学的合作者和顾问密切合作。VCTRS将解决食品和药物管理局(FDA)烟草产品中心的一个交叉和两个具体研究优先事项。交叉优先事项将是在弱势人群中研究烟草产品，包括育龄妇女/孕妇、患有其他物质使用障碍的个人以及患有严重精神疾病的个人。这些人群中的每一个都面临更高的烟草使用和依赖风险或与烟草相关的不良健康后果。然而，尽管存在这些严重的脆弱性，这些人群通常被排除在烟草监管研究之外。对于FDA有效地履行其烟草监管职责，拥有关于新烟草产品如何影响脆弱人群的可靠科学证据至关重要。我们的目标是让VCTRS协助向FDA提供这些证据。关于具体优先事项，烟草控制和预防研究中心将研究(A)通过降低香烟和其他烟草产品的尼古丁含量来降低其成瘾潜力，以及(B)审查新产品对易受伤害人群暴露和健康后果的生物标志物的影响。监管香烟和其他产品的尼古丁含量是FDA的一项重要职责，它在降低吸烟率和改善美国公共健康方面具有巨大的潜力。VCTRS将围绕四个主要目标进行组织。首先，我们将建立一个行政核心，提供必要的领导、行政和智力基础设施以及组织监督，以发展和维持一个多学科的卓越研究和培训中心。其次，我们将完成三个多地点研究项目，评估极低尼古丁含量(VLNC)香烟对脆弱人群的影响。第三，我们将建立一个项目，支持烟草监管科学的发展研究，并对时间敏感的研究优先事项做出回应。第四，发展烟草监管科学的示范性博士后和博士后培训项目。总体而言，这项建议有可能建立一个多学科中心，能够为FDA提供与其监管责任相关的至关重要的经验证据，同时还有助于在减少烟草产品成瘾性和相关的弱势人群不良健康后果方面提供新的科学知识。 相关性：那些最容易受到烟草使用的成瘾特性和不良健康后果影响的人往往也是研究最少的人，往往被明确排除在烟草研究研究之外。拟议的佛蒙特州烟草监管科学中心将专门调查在这些脆弱人群中使用新烟草产品对健康和行为的影响。

DESCRIPTION (provided by applicant): The overarching goal of this application is to establish a Vermont Center on Tobacco Regulatory Science (VCTRS). This multidisciplinary center will be located at the University of Vermont but w/ill work closely with collaborators and consultants from Brown University, Johns Hopkins University, University of Minnesota, and University of Pittsburgh. The VCTRS will address one of the crosscutting and two of the specific research priorities of the Food and Drug Administration (FDA) Center for Tobacco Products. The crosscutting priority will be researching tobacco products in vulnerable populations, including women of childbearing age/pregnant women, individuals with comorbid other substance use disorders, and individuals with comorbid serious mental illness. Each of these populations is at increased risk for tobacco use and dependence or tobacco-related adverse health outcomes. Yet despite these serious vulnerabilities, these populations are typically excluded from tobacco regulatory studies. For the FDA to effectively execute its tobacco regulatory responsibilities, having sound scientific evidence on how new tobacco products impact vulnerable populations is critically important. Our goal is for the VCTRS to assist in providing the FDA with that evidence. Regarding specific priorities, the VCTRS will research (a) reducing the addiction potential of cigarettes and other tobacco products by reducing their nicotine content and (b) examining the impact of new products on biomarkers of exposure and health outcomes in vulnerable populations. Regulating the nicotine content of cigarettes and other products is an important responsibility of the FDA that has tremendous potential to reduce smoking prevalence and improve the U.S. public health. The VCTRS will be organized around four primary aims. First, we will establish an Administrative Core that will provide the leadership, administrative and intellectual infrastructure, and organizational oversight necessary to develop and sustain a multidisciplinary center of research and training excellence. Second, we will complete three multi-site research projects evaluating the effects of very low nicotine content (VLNC) cigarettes in vulnerable populations. Third, we will establish a program to support developmental studies in tobacco regulatory science and respond to time-sensitive research priorities. Fourth, we will develop an exemplary predoctoral and postdoctoral training program in tobacco regulatory science. Overall, this proposal has the potential to establish a multidisciplinary center capable o providing the FDA with critically important empirical evidence relevant to its regulatory responsibilities, while also contributing new scientific knowledge on reducing the addictiveness of tobacco products and associated adverse health consequences in vulnerable populations. RELEVANCE: Those individuals who are most vulnerable to the addictive properties and adverse health outcomes of tobacco use are also frequently the least studied, often specifically excluded from tobacco research studies. The proposed Vermont Center of Tobacco Regulatory Science would specifically investigate the health and behavioral impacts of the use of new tobacco products in these vulnerable populations.