Biostatistics Core

生物统计核心(Bioc)的主要目标是促进成员的同行评议研究 他是维克森林大学(CCCWFU)综合癌症中心的研究员。我们对此负有责任 在与癌症相关的所有阶段与临床、癌症控制和基础科学研究人员合作 旨在减少癌症发病率和增加治疗选择的研究项目， 提高反应和存活率，减少发病率，控制症状，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。承担的主要责任是 方法学、统计学和与计算机有关的问题，包括研究设计、抽样、统计方面 临床试验监测、中期审查和最终分析。具体地说，我们负责1)确保 该研究设计是适当的，2)编写包括计划在内的所有治疗方案的统计部分 对于试验结果的中期监测，3)为第三阶段临床试验制定随机方案，4) 协助开发抽样调查工具，5)监测正在进行的议定书应计费用，6) 为CCCWFU调查人员提供方法学支持，7)执行临时数据分析，8) 执行临时和最终分析，9)合作解释和发布结果，10)参与 在CCCWFU负责CCCWFU科学和行政指导的委员会中，11) 每月为CCCWFU成员举办研究方法专题系列研讨会，并举办 定期举行统计援助规划会议，协助提交赠款申请。 在报告的一年中，从2004年7月1日到2005年6月30日，BIOC提供了超过3460个小时的 支持癌症相关工作。BIOC协助了来自所有项目的70多名不同的调查人员 CCCWFU内的卓越中心。此外，15项由调查员发起的机构议定书 开放，在生物统计的协助下，出版了18份手稿，提交了20多份赠款 在这段时间内的核心。核心所提供的一半以上的工作(1862.5小时(54%))用于执行 统计分析。额外的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%)用于给药和临床监测，110小时(3%)用于 跨越多个类别的活动。生物统计学家还提供了1.62 FTE的外部工作 在报告的年度内，以首席调查员和协理调查员的身份接受同行评审的癌症相关补助金。 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 支持，以及0.20 FTE的编程支持，为癌症中心提供这些持续服务 会员。

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 cancerrelated 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.