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.
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