Biostatistics

摘要 芝加哥大学医学综合癌症中心生物统计学核心设施(BCF) (UCCCC)为UCCCC调查人员提供协作统计支持，涉及临床、基础和 人口科学研究。该机构目前有5名博士统计员和1名硕士级人员 除科学和技术主任外，还有统计学家。BCF提供的服务包括 协作形成研究设计和数据分析计划；方案制定、随机化、 I期、II期和III期临床试验的统计分析；协助设计和 对回顾和前瞻性观测研究的分析；基础科学方面的统计协作 和动物研究项目。BCF与癌症临床试验办公室(CCTO)和 UCCCC数据库开发和数据管理程序信息技术(IT)小组 以确保在癌症中心内进行的临床试验和其他研究的高水平数据质量。 BCF还与生物信息学核心设施(BiCF)合作，以确保调查人员能够访问 特定研究所需的广泛的潜在分析服务。明确具体目标 和待检验的假设，主要、次要和相关终点的规格，样本量 (电力)计算和数据分析计划的开发是设计期间的主要活动领域 研究的阶段。在进行研究期间，BCF执行中期分析并产生应计项目 和不良事件报告。在研究完成后，BCF进行最终的统计分析和 协助准备出版手稿。BCFF成员还进行统计 方法研究，以支持在UCCCC内开展的研究项目。2013-2016年间， 论坛成员与UCCCC调查人员共同撰写了84份合作出版物，出版了16份 统计方法由UCCCC内部进行的研究激发的论文，并推动该领域 肿瘤学研究。BCF还与UCCCC调查人员合作开发新的赠款 申请。目前，BCF工作人员正在积极支持九项由NIH/NCI资助的赠款(包括 投入了百分之百的努力)，并是10项与癌症相关的拨款的联合调查人员，等待审查。Bcf 成员在UCCCC的两个主要委员会任职，这两个委员会组成了议定书审查和监测系统， 即临床试验审查委员会(CTRC)和科学应计监测委员会。 参与这些委员会确保所有方案和与癌症有关的研究项目都通过 严格的生物统计学审查和正在进行的研究的患者登记正在以最佳速度进行。 最后，BCF参与教学和辅导活动，以促进对统计的更好理解 方法对UCCCC研究人员进行问卷调查。因此，BCF在实现科学目标方面发挥着重要作用 和UCCCC的目标。

ABSTRACT The Biostatistics Core Facility (BCF) of the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) provides collaborative statistical support to UCCCC investigators engaged in clinical, basic, and population sciences research. The facility is currently staffed by five PhD statisticians and one masters-level statistician in addition to the Scientific and Technical Directors. The services provided by the BCF include collaboration in the formation of study designs and data analysis plans; protocol development, randomization, and statistical analysis for Phase I, Phase II, and Phase III clinical trials; assistance in the design and analysis of retrospective and prospective observational studies; and statistical collaboration on basic science and animal research projects. The BCF interacts closely with the Cancer Clinical Trials Office (CCTO) and the UCCCC Information Technology (IT) group on database development and data management procedures to ensure a high level of data quality for clinical trials and other studies conducted within the Cancer Center. The BCF also works with the Bioinformatics Core Facility (BiCF) to ensure that investigators have access to the broad spectrum of potential analytic services required for specific studies. Clarification of specific aims and hypotheses to be tested, specification of primary, secondary, and correlative endpoints, sample-size (power) calculations, and development of data analysis plans are major areas of activity during the design phase of a study. During the conduct of a study, the BCF performs interim analyses and generates accrual and adverse event reports. Upon completion of the study, the BCF performs final statistical analyses and assists in the preparation of manuscripts for publication. BCF members also conduct statistical methodological research in support of research projects conducted within the UCCCC. During 2013-2016, members of the BCF co-authored 84 collaborative publications with UCCCC investigators and published 16 statistical methods papers stimulated by studies conducted within the UCCCC and to advance the field of oncological research. The BCF also works with UCCCC investigators in the development of new grant applications. Presently, BCF staff are engaged in active support of nine NIH/NCI-funded grants (with committed percent effort), and are co-investigators on 10 cancer-related grants pending review. BCF members serve on two key UCCCC committees that comprise the Protocol Review and Monitoring System, i.e., the Clinical Trials Review Committee (CTRC) and the Scientific Accrual Monitoring (SAM) Committee. Participation on these committees ensures that all protocols and cancer-related research projects undergo rigorous biostatistical review and patient enrollment to ongoing studies is proceeding at an optimal pace. Finally, the BCF participates in teaching and mentoring activities to foster better understanding of statistical methods among UCCCC researchers. Thus, the BCF plays a major role in accomplishing the scientific aims and objectives of the UCCCC.