Biostatistics Core

生物统计学核心（BioC）的主要目标是促进成员的同行评审研究 维克森林大学综合癌症中心（CCCWFU）。我们负责 与临床、癌症控制和基础科学研究人员在癌症相关的所有阶段合作 旨在减少癌症发病率和增加治疗选择的研究项目， 提高反应和生存率，降低发病率，控制症状，改善与健康有关生活质量， 并将重要的实验室发现转化为临床实践。主要职责包括： 方法学、统计学和计算机相关问题，包括研究设计、抽样、统计学方面 临床试验监查、中期审查和最终分析。具体而言，我们负责1）确保 研究设计充分，2）编写所有治疗方案（包括计划）的统计部分 对于试验结果的中期监测，3）为III期临床试验制定随机化方案，4） 协助开发抽样调查工具，5）监测持续的方案累积，6） 为CCCWFU研究者提供方法学支持，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）参与 在CCCWFU委员会中负责CCCWFU的科学和行政指导，11） 每月为CCCWFU成员举办一系列关于研究方法主题的研讨会，以及12）举办 定期举行统计援助规划会议，以协助提交赠款。 在2004年7月1日至2005年6月30日的报告年度，生物技术中心提供了超过3,460小时的 支持癌症相关工作。BioC协助了来自所有项目的70多名不同的研究人员， CCCWFU内的卓越中心。此外，15项由检察官发起的机构议定书 在生物统计学的协助下，出版了18份手稿，并提交了20多份赠款。 核心在此期间超过一半的核心工作（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 方案制定，给药和临床监测570.5小时（16%）， 跨越一个以上类别的活动。生物统计学家还提供了1.62 FTE的外部工作量， 在报告年度内，作为主要研究者和合作研究者获得同行评审的癌症相关赠款。 对于拟议的资助期，我们要求1.75个全职统计支持，0.25个全职行政支持， 支持和0.20 FTE的编程支持，为癌症中心提供这些持续服务 成员

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.