Appalachian Tobacco Regulatory Science Team (AppalTRuST)

摘要 阿巴拉契亚烟草监管研究小组（AppalTRuST）的总体目标是调查 联邦药品管理局烟草制品中心（FDA CTP）监管政策对农村地区的影响 社区，一个脆弱和未得到充分研究的人口，通过合作，教育和开拓 规范性科学研究。我们的多学科团队将研究这个问题，有两个目标。 目标1.促进和开拓农村社区的监管科学研究。我们的多学科 一个研究小组将评估项目1-3的当前和潜在监管政策， 方法上的连贯性和相互关联，重点是行为的监管科学领域， 市场营销和影响分析。P1-P3将利用AppalTRuST队列解决关键监管问题 FDA CTP政策行动是否有益的问题，使个人转向危害较低的产品， 在农村社区戒烟，或没有，在某种程度上，评估结果之间的关联， 乡村水平。P1将测量与传统和新型烟草使用行为相关的因素， 产品，包括开始、进展、双重/多重烟草使用、产品转换和戒烟相关 在不同的乡村生活水平上的行为。P2将评价FDA法规如何影响使用模式 在各个乡村地区的年轻人中推广传统和新型产品。P3将使用随机 平行组试验，以评估三个拟议的烟草法规的影响，使用实验 烟草市场，以评估监管政策对农村各级使用行为的影响。 目标2.支持创新烟草监管科学并为其创造新的机会， 通过教育和合作推进TCORS研究的国家努力。以下 四个核心将支持项目，以确保中心的协调、整合和协作：（1）一个 行政核心，提供高效的协作基础设施，以加强三者之间的协同作用 计划项目和四个核心以及与更广泛的TCORS社区的合作;（2）社区 外展和参与者参与核心，使农村和郊区阿巴拉契亚社区参与， 支持我们的AppalTRuST队列;（3）生物统计学和信息学核心，以建立一个集中的，综合的数据 由统计和信息学专业知识支持的数据仓库，用于收集、协调和分析数据， 为项目和核心提供统计支持;以及（4）职业提升核心，以创建 变革性的环境，提供有指导的、多学科的和身临其境的体验， 支持TRS学者，重点是监管政策在农村地区的影响。影响：AppalTRuST 将提供所需的科学资源，以评估引进新产品的影响， 在农村社区对调味和高尼古丁产品的潜在限制， 将从健康公平的透镜出发，以多样化和异质性的农村定义为指导。

ABSTRACT The overall goal of the Appalachian Tobacco Regulatory Research Team (AppalTRuST) is to investigate the impact of Federal Drug Administration Center for Tobacco Products (FDA CTP) regulatory policies in rural communities, a vulnerable and understudied population, through collaboration, education and pioneering regulatory scientific research. Our multidisciplinary team will investigate this question with two aims. Aim 1. Facilitate and pioneer regulatory science research in rural communities. Our multidisciplinary team of researchers will evaluate current and potential regulatory policies across Projects 1-3 that are methodologically coherent and interrelated with a focus on the regulatory scientific domains of Behavior, Marketing, and Impact Analysis. P1-P3 will leverage the AppalTRuST Cohort to address the critical regulatory question of whether FDA CTP policy actions will be beneficial, shifting individuals to lower harm products or quitting tobacco in rural communities, or not, in a way that assesses the association between outcomes and level of rurality. P1 will measure the factors associated with tobacco use behaviors of conventional and novel products, including initiation, progression, dual/poly tobacco use, product switching, and cessation-related behaviors across levels of rurality over time. P2 will evaluate how FDA regulations may affect patterns of use for conventional and novel products among young adults across levels of rurality. P3 will use a randomized parallel groups trial to assess the impact of three proposed tobacco regulations using an Experimental Tobacco Marketplace to estimate effects of regulatory policies on use behavior across levels of rurality. Aim 2. Support and create new opportunities for innovative tobacco regulatory science and contribute to the national efforts to advance TCORS research through education and collaboration. The following four cores will support the projects to ensure Center coordination, integration, and collaboration: (1) an Administrative Core to provide efficient, collaborative infrastructure to enhance synergies across the three program projects and four cores as well as collaboration with the wider TCORS community; (2) a Community Outreach and Participant Engagement Core to engage rural and peri-urban Appalachian communities to support our AppalTRuST Cohort; (3) a Biostatistics and Informatics Core to build a centralized, integrated data warehouse supported by statistical and informatics expertise to collect, harmonize, and analyze data and provide statistical support for projects and cores; and (4) a Career Enhancement Core to create a transformative environment offering mentored, multidisciplinary and immersive experiences to expand and support TRS scholars, with emphasis on the impact of regulatory policies in rural areas. Impact: AppalTRuST will provide the scientific resources needed to evaluate the effects of the introduction of novel products and potential restrictions on flavored and high-nicotine products in rural communities so that regulatory decisions will be made using a health equity lens and guided by a definition of rurality that is diverse and heterogeneous.