Biostatistics Shared Resources Core

项目摘要/摘要--生物统计共享资源 生物统计共享资源(BSR)是SJCCC管理的共享资源，其首要任务是 通过生物统计合作和咨询，以及通过全面、 为中心成员提供有效、及时的生物统计支持。BSR拥有经验丰富、互动性强的 与从事前沿基础研究的研究人员协作的生物统计学家团队 5个SJCCC项目的科学、临床研究、人口和生存研究。这是 高影响力期刊的高水平合作出版物和关键科学贡献证明了这一点 如《临床肿瘤学杂志》(n=31)、《癌症》(n=31)、《自然遗传学》(n=9)和《柳叶刀肿瘤学》(n=4)。 此外，BSR生物统计学家很好地融入了提供统计支持的临床试验团队 在研究项目的整个生命周期中，从概念开发到出版。在过去的几年里 在资助期间，85%的SJCCC出版物使用了BSR，77%(n=358/468)的合作出版物使用了BSR 有一位生物统计学家作为合著者的出版物与SJCCC计划有关。这些文件包括 来自所有5个方案：CCSP(n=103)、CBP(n=1)、DBSTP(n=66)、NBTP(n=83)和HMP(n=105)。 在指数年(2017财年)，共有125名圣犹大调查人员及其工作人员使用了BSR。其中，71人 (57%)是SJCCC成员。BSR教职员工还提供研讨会、办公室咨询、讲座、研讨会、 并为研究员提供有关研究设计、分析方法和软件实现的课程， 研究人员和教职员工。BSR由Deo Kumar Sriastava博士领导，他有23年以上的经验。 有癌症研究和癌症临床试验的统计设计和分析经验。他得到了 9名教员生物统计员和13名受过硕士培训的工作人员，确保向 所有5个项目的调查人员。在我们最近的融资期间，BSR见证了增长 在加强科学计划的推动下，对儿童癌症基因组特征的研究， 并专注于复杂的精密药物，由SJCCC研究员发起的多点试验。下一笔资金的目标 期间包括继续向所有SJCCC调查人员提供最先进的统计支持，包括新的 调查人员，并有针对性地招聘生物统计学家，以加强个性化医学方面的专业知识， 免疫治疗，以及高通量大数据的扩展。最后，BSR将与 政府新闻处在实施由临床试验所提供的新软件 管理系统。

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.