ACOSOG STATISTICS AND DATA COORDINATING CENTER

美国外科学会肿瘤组（ACOSOG）统计和数据协调中心（SDCC）的主要目标是确保有效和可辩护的研究被设计、执行和报告。SDCC打算通过实施基于健全的统计原则、现代计算技术和高技能人才的临床试验管理系统来实现这一目标。自1998年5月开始资助以来，SDCC和ACOSOG作为一个整体，一直专注于启动最初的一系列研究。此时（1999年5月）有4项研究开放，有22名患者注册。为了登记患者，SDCC建立了相当大的基础设施，包括制定方案的方法、文件分发系统（网站）、数据库、患者注册程序、标准操作程序文件和患者数据采集系统。额外的支持基础设施被构建来支持两个组会议、一个委员会结构数据库和一个成员数据库。全体人员素质高，具有丰富的临床试验经验。ACOSOG有超过25项处于不同发展阶段的研究，其中一些预计将在未来几个月内开始。该提案描述了SDCC打算如何为ACOSOG的发展提供基础设施，继续招聘优秀的员工，组织效率最大化，实施与主要目标一致的政策，完善现有的系统，并在使用现代技术和概念的基础上采取新的举措。

The primary goal of the Statistical and Data Coordinating Center (SDCC) of the American College of Surgeons Oncology Group (ACOSOG) is to assure that valid and defensible studies are designed, executed, and reported. The SDCC intends to accomplish this goal by implementing clinical trials management systems based on sound statistical principles, modern computing technology, and highly skilled personnel. Since the start of funding in May of 1998, the SDCC, and the ACOSOG as a whole, have concentrated on activating the initial set of studies. At this time (May, 1999) four studies are open and there have been 22 patient registrations. In order to have registered patients, the SDCC has built a considerable infrastructure, including a methodology for the production of protocols, a document distribution system (web site), databases, patient registration procedures, Standard Operating Procedure documents, and a patient data acquisition system. Additional supporting infrastructure was built to support two group meetings, a committee structure database, and a membership database. The assembled staff is highly qualified and has extensive experience in clinical trials. The ACOSOG has over 25 studies in various stages of development, and some of these are anticipated to open in the next few months. This proposal describes how the SDCC intends to provide the infrastructure for ACOSOG growth, continue recruitment of excellent staff, organize for maximum effectiveness, implement policies consistent with the primary goal, refine the systems already in place, and undertake new initiatives based on the use of modern technologies and concepts.