Biostatistics

摘要 芝加哥大学医学综合癌症中心生物统计核心设施（BCF） （UCCCC）为从事临床，基础和临床研究的UCCCC研究人员提供协作统计支持。 人口科学研究。该设施目前有五名博士统计学家和一名硕士统计学家。 除了科学和技术主任外，还有统计学家。基金提供的服务包括 合作制定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 回顾性和前瞻性观察研究分析;基础科学统计协作 动物研究项目。BCF与癌症临床试验办公室（CTO）密切合作， UCCCC信息技术（IT）小组，负责数据库开发和数据管理程序 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，以确保研究人员能够访问 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范，样本量 （功率）计算和数据分析计划的制定是设计期间的主要活动领域 一个研究的阶段。在研究进行期间，BCF进行中期分析并生成应计费用 和不良事件报告。研究完成后，BCF进行最终统计分析， 协助准备出版手稿。BCF成员还进行统计 方法研究，以支持UCCCC内进行的研究项目。2013-2016年期间， BCF的成员与UCCCC的研究人员共同撰写了84份合作出版物，并出版了16份 在UCCCC内部进行的研究所激发的统计方法论文，并推动该领域的发展， 肿瘤学研究BCF还与UCCCC研究人员合作开发新的赠款 应用.目前，BCF工作人员正在积极支持九个NIH/NCI资助的赠款（ 致力于百分之努力），并共同调查10癌症相关赠款等待审查。BCF 成员服务于两个关键的UCCCC委员会，包括议定书审查和监测系统， 也就是说，临床试验审查委员会（CTRC）和科学应计监测委员会（SAM）。 参加这些委员会可确保所有方案和与癌症有关的研究项目都能得到执行。 严格的生物统计学审查和正在进行的研究的患者招募正在以最佳的速度进行。 最后，BCF参与教学和辅导活动，以促进更好地了解统计 UCCCC研究人员的方法。因此，生物多样性基金在实现科学目标方面发挥着重要作用 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.