Pl an Study design • Sample size needs Analyze pilot data Proposal preparation CON DUCT Interim analyses • DSMB support Monitoring Analyze Data QA/QC • Data analysis Interpretation UC Davis CTSC Biostatistics Pu blish Manuscript preparation Response to reviewers Enhancing clinical and translational research by providing statistical expertise to investigators Contact Us For more information about biostatistical services available through the CTSC contact: Statistical consultation Grant proposal preparation Sandra Taylor, Ph.D. Study design/protocol development Senior Statistician 916-703-9171 Statistical analysis plan preparation sltaylor@ucdavis.edu www.ucdmc.ucdavis.edu/ctsc Data analysis and interpretation DSMB participation or visit our website: www.ucdmc.ucdavis.edu/ctsc/area/ biostatistics/index.html The UC Davis CTSC is a member of the national CTSA consortium and supported by award TR000002 from the National Institutes of Health’s National Center for Advancing Translational Sciences. The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS. www.ucdmc.ucdavis.edu/ctsc Getting Assistance Services Offered Weekly Biostatistics Office Hours Overview Study Design/Protocol Development Successful investigators recognize the benefits of including statisticians in their research projects. Statisticians help ensure that the study design is powerfully and cost-efficiently matched to study objectives, that necessary data to address those study objectives are collected, and that appropriate statistical analyses are conducted and reported. These conditions are vital for successful research. Input on study design and protocol development, including: The CTSC Biostatistics group provides statistical support for all phases of research from designing the study and analyzing the data through publishing the results. We serve a wide range of clinical and translational researchers across disciplines and all sizes and types of projects, from simple data analyses to large, multi-center clinical trials. Biostatistical Consultation Statistical advice on specific statistical issues or preliminary discussion to determine the scope and needs of a specific project. Grant Proposal Preparation Assistance with grant proposal preparation, including: Refining study specific aims Developing the study design Determining sample size requirements Preparing a statistical analysis plan Crafting proposal sections related to statistics Determining study structure/approach (e.g., two-arm study, case-control study) Defining control population Establishing randomization procedures Developing matching criteria and/or strata Specifying interim analysis procedures Conducting sample size calculations Statistical Analysis Planning Consultation on appropriate statistical methods for analyzing a data set to address the specific aims of a study. Data Analysis and Interpretation Statistical analysis of data using state-of-the-art methods and software. Our highly skilled statisticians work closely with investigators to understand their research objectives and conduct appropriate and meaningful analyses. DSMB Support Biostatistician participation on the DSMB for your clinical trial and conduct of statistical assessments defined in the study protocol for the DSMB. Tuesday, 12 :00 – 1:30 p.m. at the CTSC Receive input from a statistician about the design, analysis or presentation of your medical research in a friendly, informal setting. Reserve a time at https://ctscbiostatisticsworkshop.acuityscheduling. com/schedule.php Request Services Investigators can request more in-depth biostatistics assistance through the CTSC, and one of our statisticians will be assigned to work with you individually. To request assistance go to www.ucdmc. ucdavis.edu/ctsc/ and submit a request for services. Investigators who only need statistical advice are encouraged to attend the weekly office hours rather than to submit a formal assistance request. Rates for Services The Biostatistics group is supported in part by funding from the CTSA NIH grant and the UC Davis School of Medicine. This funding allows us to provide some services without charge. Grant proposal preparation and analysis of preliminary data in support of grant applications receive highest priority for unfunded efforts. For other biostatistical assistance (e.g., data analysis), unfunded support is limited to 10 hours. In all cases, projects supported by extramural funding must provide salary cost recovery for professional statistical services at a level commensurate with the available funding and level of effort.