Vermont Center on Tobacco Regulatory Science

描述（由申请人提供）：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）烟草制品中心的一个横切和两个具体研究重点。交叉优先事项将是研究弱势人群中的烟草制品，包括育龄妇女/孕妇、患有其他物质使用障碍的患者以及患有合并严重精神疾病的患者。这些人群中的每一个都面临着烟草使用和依赖或与烟草相关的不良健康后果的风险增加。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，关于新烟草产品如何影响弱势群体的可靠科学证据至关重要。我们的目标是让VCTRS协助向FDA提供证据。关于具体的优先事项，VCTRS将研究(a)通过减少香烟和其他烟草产品的尼古丁含量来减少其成瘾性，以及(b)审查新产品对易受伤害人群接触生物标志物和健康结果的影响。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众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研究和卓越培训中心。第二，我们将完成三个多站点研究项目，评估极低尼古丁含量（VLNC）香烟对弱势人群的影响。第三，我们将建立一个项目，支持烟草监管科学的发展性研究，并对具有时效性的研究重点作出反应。四是建设烟草监管科学博士前、博士后示范性培养计划。总体而言，该提案有可能建立一个多学科中心，能够为FDA提供与其监管职责相关的至关重要的经验证据，同时也为减少烟草制品的成瘾性和弱势群体相关的不良健康后果提供新的科学知识。

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.