ACOSOG STATISTICS AND DATA COORDINATING CENTER

ACOSOG 统计和数据协调中心

• 批准号: 6514487
• 负责人: SAMUEL A WELLS
• 金额: $ 187.45万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-01 至 2005-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6514487
• 关键词: clinical research; clinical trials; cooperative study; data collection; data management; experimental designs; human data; neoplasm /cancer therapy; statistics /biometry

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.

美国外科医师学会肿瘤学小组(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。国家疾病预防控制中心打算通过实施基于健全的统计原理、现代计算机技术和高技能人员的临床试验管理系统来实现这一目标。自1998年5月开始提供资金以来，可持续发展协调委员会和ACOSOG作为一个整体，一直专注于启动最初的一套研究。目前(1999年5月)有4项研究开放，已有22名患者登记。为了登记病人，SDCC建立了相当大的基础设施，包括方案的编制方法、文件分发系统(网站)、数据库、病人登记程序、标准操作程序文件和病人数据采集系统。建立了额外的辅助基础设施，以支持两个小组会议、一个委员会结构数据库和一个成员数据库。组装的工作人员素质很高，在临床试验方面有丰富的经验。ACOSOG有超过25项研究处于不同的发展阶段，其中一些研究预计将在未来几个月内开始。这份提案描述了SDCC打算如何为ACOSOG的发展提供基础设施，继续招聘优秀的工作人员，为最大限度地发挥效力而进行组织，执行与主要目标一致的政策，完善现有的制度，并基于现代技术和概念采取新的举措。