Sub-component for Institution # 16-01848 Biostatistics

点击翻译按钮获取中文摘要

The primary goal of the Biostatistics Core (Core 2) will be to provide cost-effective, comprehensive and critical support to the four projects and cores from this P01 application entitled “Maximizing Local Access to Therapeutic Deliveries in Glioblastoma”. To do this Core 2 has assembled a team of experienced faculty and staff statisticians and programmers. The Biostatistics Core will also act as a central resource throughout all phases of the project. Members of Core 2 will assume (and has assumed) major responsibilities for methodological, statistical, and computer-related issues, including study design for all projects; data collection, data entry, and analyses; quality control; computer networking; database management; statistical methodology development; and participation in manuscript preparation. Core 2 has worked with each Project Leader to insure that each study design is adequate to address all major hypotheses. This has involved refining study hypotheses, defining primary (and when necessary, secondary) end points for each study; determining the sample sizes necessary to test each hypothesis with a specified power and level of significance, and assessing the feasibility of each study relative to its hypothesis and the projected available subject pool. Core 2 has taken care to design the statistical analysis plans for each project to contain a combination of standard and advanced statistical methods as needed. This includes using methods for longitudinal data that account for repeated measures as well as handling missing data if it were to occur. In addition, Core 2 members will look for opportunities to develop new statistical methods for analyzing imaging data and these approaches are described in the proposal. To guarantee that successful implementation of these methods occurs, Core 2 members are committed to taking an active part in the daily activities of each project. For each project one of Core 2 members will serve as a co-investigator and participate in regular meetings among investigators for that project. This model of collaboration among Core 2 members and scientific investigators has been implemented within the Cancer Center at Wake Forest University for many years with great success. In conclusion, the Biostatistics Core is an integral component of this P01. It connects the four projects together and supports all other Cores by providing centralized analytic and data management support that will allow efficient dissemination of results to flow among projects and cores, and into the scientific community.