Biostatistics Core

生物统计核心（BioC）的主要目标是促进维克森林大学综合癌症中心（CCCWFU）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，增加治疗选择，提高反应和生存率，降低发病率，管理症状，改善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问题，包括研究设计、抽样、临床试验监测的统计方面、中期审查和最终分析。具体来说，我们负责1)确保研究设计是充分的，2)编写所有治疗方案的统计部分，包括试验结果的中期监测计划，3)为III期临床试验制定随机化方案，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研究者提供方法学支持，7)进行中期数据分析，8)进行临时分析和最终分析，9)合作解释和发表结果，10)参加CCCWFU委员会，负责CCCWFU的科学和行政指导，11)为CCCWFU成员举办每月一次的研究方法主题系列研讨会，12)定期举行统计协助计划会议，以协助申请资助。

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.