Grant Number:	5P50CA180908-03 Interpret this number
Primary Investigator:	Wewers, Mary
Organization:	Ohio State University
Project Title:	Osu Center of Excellence in Regulatory Tobacco Science (Osu-Certs)
Fiscal Year:	2015

DESCRIPTION (provided by applicant): 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, the OSU-CERTS includes projects with shared cohorts, theory, and/or measures; all projects will provide data for urban and rural settings to enhance generalizability. Included are four projects, all sampled from the same methodology (address based sampling), where some households will be shared by companion projects and other households will be used for other projects. Companion Projects 1 and 2 will utilize a three year cohort of adolescents and their families to compare and establish the prevalence of smoking, ST use and dual use, and tobacco-use risk factors with an emphasis on environment, advertising and marketing, and trajectories to regular use. This cohort study will include an assessment of carcinogen exposure, and genetics for taste perception and tobacco use behavior. Project 3 will establish a 3 year cohort of adults to characterize the diversity of types of tobacco products used overtime and examine individual, cognitive and affective risk factors. It will consider purchasing factors and marketing practices in retail environments. Project 4 will be several experimental studies that examine psychological constructs and decision making models for choosing tobacco products. The OSU-CERTS includes five cores (A-E) to provide resources to all projects. Cores include: 1) Administrative (Core A); 2) Recruitment, Survey and Retention (Core B); 3) Biostatistics and Data Resources (Core C); 4) Developmental and Pilot Research (Core D); and 5) Research Training and Education (Core E). The OSU-CERTS infrastructure and cores will set the foundation for current and future scientific discoveries that will assist th FDA. It currently addresses 11 of 56 research priorities set forth by the FDA in January, 2012. Institutional commitment includes recruitment of new faculty and funding for junior faculty, postdoctoral fellows and pilot projects. OSU-CERTS is an investment that trains the next generation of scientists and policy experts, funds innovative pilot projects and establishes relevant cohorts. RELEVANCE: OSU-CERTS will assist to improve public health and reduce population harm from tobacco product use. Harm involves individual disease risk and prevalence of product use. OSU-CERTS will conduct a series of projects to provide information about the relationships between ever-changing diverse types of tobacco product use among rural (Appalachian OH) and urban (Columbus OH) adolescents and adults at risk for tobacco-attributable disease and death. This information assists the FDA to regulate harmful products.





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