This core will provide professional and administrative functions to all our other cores and projects. The overall goal of our center is to provide a comprehensive assessment of the biological effects of new and emerging tobacco products (NETPs). As of now, we have chosen to focus on little cigars and hookahs; however, since new tobacco products are constantly emerging, oversight will be needed, in conjunction with input from other TCORS groups and in the light of new research, regarding which tests to prioritize and products to focus on. Such issues will be routinely evaluated by this core. This will be achieved by regular consultation of the PIs with the Oversight Committee, the Project Leaders and the Core Directors. This core will take full responsibility for advising other groups as to the biological effects of NETPs in a timely manner, either by frequent phone/web interactions or with less frequent but equally important direct meetings. Such interactions will be invaluable for disseminating information, gathering novel technical advice from other groups, standardizing approaches between groups and receiving advice on which products are the most relevant to study. Additionally, since our projects plan to obtain induced sputum, bronchoalveolar lavage, lower airways epithelial cells and excised lungs from human subjects, as well conducting studies using mouse models, this core will also facilitate our Human Rights Protocol and IACUC submission in compliance with all Federal/University guidelines for in vivo research.
This core will also be responsible for providing bioanalysis support for the entire center. Specifically, this core’s bioinformatician and biostatistician will provide support in research design, conduct, data management and analysis for all our projects and cores. This will include preparation of codebooks, assignment of ID numbers, integration of databases, and data quality control. For example, statistical analysis plans will be developed for each project, outlining the statistical methods to be used to address the study hypotheses. The analysis plans will include a clear statement of the study objectives and the hypotheses defined to meet those objectives. The primary and secondary endpoints and statistical methods for analyzing each endpoint will be specified. We hope that the inclusion of biostatisticians within this core will help the PIs and Core Directors of the P50 achieve the goals and specific aims that are required to make this a successful TCORS program.