Biostatistics Core

生物统计学核心(Bioc)的主要目标是促进维克森林大学(CCCWFU)综合癌症中心成员的同行评议研究。我们负责在癌症相关研究项目的所有阶段与临床、癌症控制和基础科学研究人员合作，旨在降低癌症发病率和增加治疗选择，提高反应和存活率，减少发病率，管理症状，提高与健康相关的生活质量，并将重要的实验室发现转化为临床实践。主要负责方法学、统计学和计算机相关的问题，包括研究设计、抽样、临床试验监测的统计学方面、中期审查和最终分析。具体地说，我们负责1)确保研究设计充分，2)编写所有治疗方案的统计部分，包括试验结果中期监测计划，3)制定第三阶段临床试验的随机方案，4)协助开发样本调查工具，5)监测正在进行的方案累积，6)为CCCWFU调查人员提供方法学支持，7)进行中期数据分析，8)进行特别和最终分析，9)合作解释和发布结果，10)参加CCCWFU负责CCCWFU科学和行政指导的委员会，11)每月为CCCWFU成员举办研究方法专题系列研讨会，12)定期举行统计援助规划会议，协助提交赠款申请。 在报告的年份，即2004年7月1日至2005年6月30日，BIOC为癌症相关工作提供了超过3460小时的支持。BIOC协助了CCCWFU内所有项目和英才中心的70多名不同的调查人员。此外，在此期间，在生物统计核心的协助下，开展了15项由调查员发起的机构方案，出版了18份手稿，并提交了20多份赠款。核心提供的工作有一半以上(1862.5小时(54%))用于执行统计分析。另外589.5小时(17%)用于赠款开发，329小时(10%)用于方案开发，570.5小时(16%)用于管理和临床监测，110小时(3%)用于连接多个类别的活动。在报告的一年中，生物统计学家还为外部同行评审的癌症相关赠款提供了1.62 FTE的工作，作为首席调查员和联合调查员。 在建议的授权期内，我们要求1.75 FTE的统计支持、0.25 FTE的行政支持和0.20 FTE的编程支持，以向癌症中心成员提供这些持续服务。

The primary goal of the Biostatistics Core (BioC) is to facilitate the peer-reviewed research of members of the Comprehensive Cancer Center at Wake Forest University (CCCWFU). We are responsible for collaborating with clinical, cancer control and basic science investigators throughout all phases of cancer-related research projects designed to reduce the incidence of cancer and increase treatment options, improve response and survival, reduce morbidity, manage symptoms, improve health-related quality of life, and move important laboratory discoveries into clinical practice. Major responsibilities are assumed for methodological, statistical, and computer-related issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analysis. Specifically, we are responsible for 1) ensuring that study designs are adequate, 2) writing the statistical sections for all treatment protocols including plans for interim monitoring of trial results, 3) developing randomization schemes for phase III clinical trials, 4) assisting with the development of sample survey instruments, 5) monitoring ongoing protocol accrual, 6) providing methodological support to CCCWFU investigators, 7) performing interim data analyses, 8) performing ad hoc and final analyses, 9) collaborating in interpreting and publishing results, 10) participating in CCCWFU committees responsible for the scientific and administrative direction of the CCCWFU, 11) conducting a monthly seminar series on topics in research methods for CCCWFU members, and 12) holding statistical assistance planning sessions regularly to assist with grant submissions. In the reported year, July 1, 2004 through June 30,2005, the BioC provided over 3,460 hours of support for cancer related work. The BioC assisted over 70 different investigators from all Programs and Centers of Excellence within the CCCWFU. In addition, 15 investigator-initiated institutional protocols were opened, 18 manuscripts were published and over 20 grants submitted with the assistance of the Biostatistics Core during this time. Over half of the effort provided by the Core (1862.5 hours (54%)) was for performing statistical analyses. An additional 589.5 hours (17%) were spent on grant development, 329 hours (10%) on protocol development, 570.5 hours (16%) on administration and clinical monitoring, and 110 hours (3%) on activities that bridged more than one category. Biostatisticians also provided 1.62 FTEs of effort on external peer-reviewed cancer-related grants as Principal Investigators and Co-investigators during the reported year. For the proposed grant period, we request 1.75 FTEs of statistical support, 0.25 FTEs of administrative support, and 0.20 FTEs of programming support to provide these continued services to Cancer Center members.