Rutgers Center of Excellence in Rapid Surveillance of Tobacco

罗格斯大学烟草快速监测卓越中心

• 批准号: 10624554
• 负责人: CRISTINE D DELNEVO
• 金额: $ 279.96万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10624554
• 关键词: Attention; Authorization documentation; Behavior; Case Study; Characteristics; Cigar; Cigarette; Collaborations; Communities; Complex; Data; Data Analyses; Data Collection; Data Sources; Descriptor; Detection; Disparity; Early identification; Electronic cigarette; Emerging Tobacco Products; Ensure; Evolution; Growth; High Prevalence; High School Student; JUUL; Knowledge; Maps; Marketing; Measurement; Measures; Menthol; Methods; Modernization; Modified Risk Tobacco Product; Monitor; Newspapers; Pathway interactions; Persons; Population; Population Surveillance; Positioning Attribute; Price; Process; Public Health; Reporting; Resources; Sales; Sentinel; Shapes; Signal Transduction; Site; Smokeless; Smokeless Tobacco; Spottings; Surveillance Methods; Surveys; System; Time; Tobacco; Tobacco Surveillance; Tobacco use; Youth; authority; behavior change; college; electronic cigarette use; experience; high school; improved; interest; medical specialties; multiple data sources; news; non-cigarette tobacco product; programs; response; social media; standardize measure; tobacco advertising; tobacco control; tobacco products; tobacco regulation; tobacco regulatory science; uptake; web site; young adult

ABSTRACT The 2009 Tobacco Control Act (TCA) gave the FDA authority to regulate tobacco products to protect public health but initially extended only to cigarettes. By the time other products were deemed under FDA authority in 2016, the tobacco landscape had changed dramatically, making modern tobacco surveillance increasingly complex. Unfortunately, the cigarette-centric tobacco surveillance systems in the US have been slow to respond to these changes. Even after formal calls for improvements in smokeless tobacco and cigar measurement more than 20 years ago, standardized measures of these products remain sparse and insufficient. Moreover, despite numerous early warning signals, questions about JUUL did not appear on major national surveys such as National Youth Tobacco Survey until 2019, two full years after it became the top- selling ENDS brand on the market and ENDS use among youth had reached concerning levels. Indeed, rapid assessment and response to changes in the tobacco market are essential to informing and evaluating FDA’s current and pending regulatory actions, including proposed product standards (e.g., banning menthol), pending marketing authorizations for e-cigarettes, and the modified risk tobacco products (MRTPs) pathway. Therefore, informed by a conceptual framework which draws upon a traditional public health surveillance perspective as well as FDA’s Sentinel Initiative, this U01 proposal assembles a large collaborative network, which includes a network of six sentinel states that triangulates multiple data sources to establish the Center for Rapid Surveillance of Tobacco (CRST). The CRST aims to perform rapid surveillance of: 1) tobacco product marketing, to generate signals of interest; 2) the tobacco product marketplace, to generate and refine signals of interest; and 3) changes in tobacco product use behaviors, to generate, refine, and evaluate signals of interest. We will implement an optimal rapid surveillance system of tobacco that will enhance FDA’s regulation of tobacco products using a range of methods and subject matter experts to rapidly assess meaningful changes in tobacco marketing, the tobacco marketplace, and tobacco use. The team assembled has deep experience with tobacco regulatory science, surveillance and analyses of these data. We also have extensive experience overseeing multi-site projects in collaboration with federal partners that support our ability to carry out the administrative aspects of CRST. Our ongoing engagement with FDA CTP, federal partners, and CASEL and deep knowledge of FDA’s regulatory authority and processes ensure that we will not only conduct rapid surveillance, but anticipate changes in the market via early signal detection, and deliver meaningful data to inform FDA’s activities and support a substantial public health impact. In doing so, we will establish a new paradigm of tobacco surveillance, serve as a resource on surveillance methods and measures, support evolutions in traditional surveillance measures, and meaningfully advance the field of tobacco regulatory science.

抽象的 2009年《烟草控制法》（TCA）授予FDA授权，以规范烟草产品以保护公众 健康，但最初仅扩展到香烟。到其他产品被视为FDA授权时 2016年，烟草景观发生了巨大变化，使现代烟草监视越来越多 复杂的。不幸的是，美国以公民为中心的烟草监视系统的速度很慢。 回应这些变化。即使在正式呼吁改善无烟烟草和雪茄之后 20多年前的测量，这些产品的标准化度量仍然很稀疏， 不足的。此外，绝望的众多预警信号，关于Juul的问题没有出现在少校上 全国性调查，例如全国青年烟草调查，直到2019年，这是最重要的两年 在市场上销售目的品牌，而青年人之间的末端使用已经达到了水平。确实，快速 评估和对烟草市场变化的反应对于告知和评估FDA至关重要 当前和未决的监管行动，包括拟议的产品标准（例如，禁止心态），待定 电子烟的营销授权以及修改的风险烟草产品（MRTPS）途径。所以， 通过一个概念框架的信息，该框架利用了传统的公共卫生监视观点 以及FDA的Sentinel倡议，该U01提案组装了一个大型协作网络，其中包括一个 六个哨兵的网络指出，三角调整多个数据源以建立快速中心 烟草（CRST）的监视。 CRST旨在执行以下快速监视：1）烟草产品 营销，产生感兴趣的信号； 2）烟草产品市场，生成和完善信号 感兴趣的3）烟草产品使用行为的变化，以生成，完善和评估信号 兴趣。我们将实施最佳的烟草快速监视系统，以增强FDA的监管 使用一系列方法和主题专家快速评估有意义的烟草产品 烟草营销，烟草市场和烟草使用的变化。团队聚集很深 有烟草监管科学，监视和分析这些数据的经验。我们也有广泛的 经验与联邦合作伙伴合作监督多站点项目的经验，这些项目支持我们的携带能力 消除CRST的管理方面。我们与FDA CTP，联邦合作伙伴和 CASEL和对FDA的监管权威和流程的深入了解，确保我们不仅会行动 快速监视，但可以通过早期信号检测预测市场的变化，并提供有意义的数据 为FDA的活动提供信息并支持实质性的公共卫生影响。这样，我们将建立一个新的 烟草监视的范式，作为监视方法和措施的资源，支持 传统监视测量中的进化，并有意义地推进了烟草监管的领域 科学。