Core D: Developmental/Pilot Research Core p367-377

俄亥俄州立大学管理烟草科学卓越中心(OSUCERTS)的核心 建议为以下项目开发、实施和评估开发/试点研究核心(DPRC 烟草监管科学。俄亥俄州立大学监管卓越中心的总体愿景 烟草科学(OSU-CERTS)将作为国家领导者提供相关的科学数据来支持 FDA在烟草产品中心的监管决策。OSU-CERTS的总体主题是 了解潜在的烟草产品偏好的原因，特别是双重用途和多种用途，以及如何 这些原因影响了在不断变化的不同类型烟草产品环境中的使用。《中心》 将把这一主题纳入在自然环境中进行的一系列青少年和成人队列研究中， 辅以控制良好的实验研究，允许进行因果推断。要完成以下任务 上面，我们将利用人口伤害模型，其中对人口的伤害是个别疾病的结果 风险和接触者的人数(流行率)。OSU-CERTS的主要研究领域 这将有助于FDA包括广告和营销的影响；认知和情感影响 决策；关注无烟烟草(ST)和双重用途；利用城市和农村人口 加强普适性；以及涵盖从青少年到 成年人。我们的中心将解决FDA在2012年1月提出的56项研究优先事项中的11项。初级阶段 DPRC的目标是在我们现有研究项目的基础上再接再厉，并建立新的具有发展潜力的项目 资金；试点项目可能涉及OSU-CERTS FDA目前的11个研究优先事项，或新的优先研究事项。 将鼓励能够支持跨TCOR研究的飞行员。人们会期望获奖者 利用OCU-CERTS研究基础设施和核心。检讨机制将由 综合癌症中心(CCC)的内部研究计划，应该被认为是制度性的 支持。如下所述，飞行员的例子包括对图形警告图像和眼睛的评估 跟踪；以及对有关新兴产品的行业文件的研究。总计60万美元将资助20名飞行员 在赠款的2-5年期间，其中包括来自CCC的机构支持。

This Core of The Ohio State University Center of Excellence in Regulatory Tobacco Science (OSUCERTS) proposes to develop, implement, and evaluate the Developmental/Pilot Research Core (DPRC) for tobacco regulatory science. The overall vision of The Ohio State University Center of Excellence in Regulatory Tobacco Science (OSU-CERTS) is to serve as a national leader in providing relevant scientific data to support FDA regulatory decision making in the Center for Tobacco Products. The overall theme of OSU-CERTS is to understand the reasons for underlying tobacco-product preferences, especially dual and poly-use, and how these reasons influence use in an environment of ever-changing diverse types of tobacco products. The Center will integrate this theme in a series of adolescent and adult cohort studies conducted in natural settings, complemented by well-controlled experimental studies that allow for causal inference. To accomplish the above, we will utilize a population harm model, where harm to the population is the result of individual disease risk and the number of persons who are exposed (prevalence). The major research areas of the OSU-CERTS that will assist the FDA include the impact of advertising and marketing; cognitive and affective influences in decision making; a focus on smokeless tobacco (ST) and dual use; use of both urban and rural populations to enhance generalizability; and synergistic studies that cover the range of tobacco users from adolescents to adults. Our Center will address 11 of 56 research priorities set forth by the FDA in January, 2012. The primary goal of the DPRC is to build upon our existing research projects and also to establish new ones with developmental monies; pilot projects may address the 11 current OSU-CERTS FDA research priorities, or new ones. Pilots that can support research across TCORS will be encouraged. There will be an expectation that awardees utilize the OCU-CERTS research infrastructure and cores. The review mechanism will be provided by the Comprehensive Cancer Center's (CCC) Intramural Research Program, which should be considered institutional support. Examples of pilots, as described below, include an evaluation of graphic warning images and eye tracking; and a study of industry documents about emerging products. A total of $600,000 will fund 20 pilots over years 2-5 of the grant, which includes institutional support from the CCC.