This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Introduction: The overall mission of the Statistical Core is to provide support in the areas of study design, sample size estimation/statistical power analyses, statistical methodology and database management for the projects in the COBRE. The Statistical Core has a crucial role in not only providing statistical services but in contributing to the mentoring process for the junior principal investigators (JPIs) in developing their understanding of the importance of study design and data analysis. Objective: The activities of the Statistical Core are guided by the following 5 specific aims. (1) Consultation with Junior Principle Investigators (JPIs) on study design, sample size estimation, statistical analysis plan, and research proposal. (2) Development and management of database management system and quality control procedures. (3) Statistical analysis of study data, presentation and interpretation of results. (4) Educational services to support investigator development in study design and analysis. (5) Enhancement of statistical core services to bring state of the art capabilities to the COBRE.Methods: The Statistical Core members (Drs. Mercante, Peters, and Simonsen, and Mr. Hagan) regularly attend seminars, chalk talks, grantseekers, invited talks presented by or at the request of the JPIs. In addition, Dr. Mercante regularly attends secondary mentor meetings for the JPIs. Members of the Statistical Core are available to each JPI to review and advise JPIs on grant submissions, abstract and paper preparations and submission. All members of the Statistical Core actively participate in developing and presenting lectures in a 10-part didactic series specifically structured to meet the needs and interests of the current JPI team.Results: The Statistical Core successfully recruited a M.S. biostatistician, Mr. Joseph Hagan, into the Statistical Core to take over the responsibilities Ms. Joanna Du, who resigned in late 2007 when her husband was relocated to Washington, D.C. Drs. Mercante, Peters, and Simonsen and Mr Joe Hagan all presented seminars as part of the didactic series to the JPIs. Topics included basic epidemiological study design and measures, design and analysis issues in statistics and clinical trials, and database management. Dr. Mercante has collaborated with Dr. Xu on his grant submission and re-submission, providing advice on experimental design, sample size estimation and statistical analysis.Discussion: The Statistical Core has made significant progress towards the stated objectives and will continue to work closely with the JPIs to provide guidance and support for their research. In particular, the Statistical Core has greatly expanded and enhanced its didactic series and website for providing statistical resources to the JPIs. Dr. Mercante has met with Dr. Xu on multiple occasions to discuss enhanced statistical support of his R01 application.
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