Biostatistics Shared Resources Core

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PROJECT SUMMARY/ABSTRACT— Biostatistics Shared Resource The Biostatistics Shared Resource (BSR) is a SJCCC managed shared resource with the overarching mission of impacting pediatric cancer through biostatistics collaboration and consulting, and through comprehensive, effective, and timely biostatistical support to Center members. BSR has a highly experienced and interactive team of biostatisticians who work collaboratively with researchers who are conducting leading edge basic science, clinical research, and population and survivorship research from the 5 SJCCC Programs. This is evidenced by the high level of collaborative publications and key scientific contributions in high-impact journals such as Journal of Clinical Oncology (n=31), Cancer (n=31), Nature Genetics (n=9), and Lancet Oncology (n=4). In addition, BSR biostatisticians are well integrated into the clinical trial teams providing statistical support throughout the life cycle of the research project from concept development through publication. During the last funding period, 85% of all SJCCC publications used the BSR and 77% (n=358/468) of all collaborative publications with a biostatistician as a co-author were associated with SJCCC programs. These included papers from all 5 of the programs: CCSP (n = 103), CBP (n = 1), DBSTP (n = 66), NBTP (n = 83), and HMP (n = 105). A total of 125 St. Jude investigators and their staff used the BSR during the index year (FY2017). Of those, 71 (57%) were SJCCC members. The BSR faculty also offer workshops, office consultations, lectures, seminars, Grand Rounds, and courses on study design, analysis methods, and software implementation to fellows, research staff, and faculty. The BSR is led by Dr. Deo Kumar Srivastava who has more than 23 years' experience in the statistical design and analysis of cancer research and cancer clinical trials. He is supported by 9 faculty biostatisticians and 13 master's-level trained staff, ensuring that BSR support is available to investigators throughout all 5 programs. During our most recent funding period, BSR has witnessed growth driven by the strengthening of the scientific programs, research in genomic characterization of pediatric cancers, and focus on complex precision medicine SJCCC investigator-initiated multisite trials. Goals for the next funding period include continuing to provide state-of-the-art statistical support to all SJCCC investigators including new investigators, and targeted recruitment of biostatisticians to strengthen expertise in personalized medicine, immunotherapy, and in expansion of high-throughput big data. Lastly, BSR will closely partner with the Information Services department in the implementation of the new software provided by the Clinical Trials Management System.