BIOSTATISTICS SHARED RESOURCE ABSTRACT The Biostatistics Shared Resource (BSR) provides comprehensive biostatistics support and collaboration for cancer research projects conducted by Moores Cancer Center (MCC) investigators. Established in 1995, the BSR has been led by Karen Messer since 2006, with additional leadership support from Loki Natarajan, both nationally recognized biostatisticians with distinguished track records in cancer research. The BSR has strong ties to the academic resources of the UCSD Division of Biostatistics. The BSR comprises 8.6 FTE of cancer- funded effort, including 6 faculty and 8 staff biostatisticians at the PhD or Master?s level. In addition, there is a full-time Project Manager, who also coordinates clinical trials support between the BSR, study teams, and the Clinical Trials Office. BSR faculty and staff have offices on the third floor of the MCC building, creating a Biostatistics suite with well-defined signage. Key objectives of the BSR include biostatistics support of new grant applications, and support for design, analysis, interpretation of results and manuscript preparation for cancer-related studies. The BSR also supports 24-CFR-part-11 compliant data capture for investigator-initiated clinical trials using VELOS clinical trials management software, as well as data and safety monitoring, Data and Safety Monitoring Committee (DSMC) reporting, as well as interim and final analyses. The BSR supports statistical review for the Protocol Review and Monitoring Committee (PRMC) and DSMC. BSR services are divided between short-term consulting supported by the CCSG without charge to MCC investigators, and longer-term collaboration that is funded from collaborative grants. Service requests are accepted in person, by phone, email, or web request, and are tracked using a web-based system. Improvements during the reporting period have been recruitment of new participating Biostatistics faculty with addition of specialized expertise in natural language processing and in image analysis, an increase in the total statistical FTE in the BSR, and increased training in Cancer Biostatistics through outreach to MCC members and coordination with the UCSD Biostatistics PhD program. Future plans include moving towards Clinical Data Interchange Standards Consortium (CDISC) compliant data capture, and further diversifying key areas of biostatistics faculty expertise through additional recruitments. During the period 2013-2017, the BSR supported 150 different investigators, co-authored 136 cancer-related, peer-reviewed papers, and assisted with 215 grant submissions. Furthermore, the BSR assisted in developing 73 therapeutic protocols, with 21 currently active and 13 recently completed therapeutic studies. 124 MCC members representing all 5 programs used BSR services, accounting for 89% of shared resource utilization. The BSR received 20% of its funding from the CCSG.
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