TERRY BEIRN COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON

艾滋病临床研究社区计划 (CPCRA) 是一个以社区为基础的临床试验小组，拟包括美国的 19 个单位以及澳大利亚、加拿大和英国的临床中心。这是针对该试验组的统计和数据管理中心 (SDMC) 的提案。 SDMC 对随附核心提案中概述的科学议程的统计部分承担主要责任。 SDMC 还主要负责制定数据收集、管理和报告程序，以确保研究得到正确实施和监测。目标分为四个广泛且相互关联的领域： l) 通过合作制定综合科学议程、在研究设计中使用创新方法、进行中期和最终分析以及举办研究方法研讨会，为小组提供统计领导； 2）继续加强及时有效地收集、处理和报告数据的系统，以实现研究目标； 3) 与澳大利亚、加拿大和英国的国家试验协调中心合作，协助随机化程序、数据管理和数据分析，并与其他临床试验小组就具体研究进行合作； 4) 与 CPCRA 中的所有组织团体和委员会密切合作，执行科学议程，并维持与更大的 CPRA 组织保持一致的 SDMC 组织结构和工作人员，并提供积极的工作氛围和同行支持。

The Community Programs for Clinical Research on AIDS (CPCRA) is a community-based clinical trials group which proposes to include 19 units in the United States and clinical sites in Australia, Canada, and the United Kingdom. This is a proposal for the Statistical and Data Management Center (SDMC) for this trials group. The SDMC bears primary responsibility for the statistical components of the science agenda outlined in the accompanying core proposal. The SDMC also has primary responsibility for the development of data collection, management, and reporting procedures that ensure that the studies are properly implemented and monitored. Objectives fall into four broad and interrelated areas: l) to provide statistical leadership to the group by collaborating on the development of an integrated scientific agenda, by using innovative approaches in the design of studies, by carrying out interim and final analyses, and by conducting seminars on research methods; 2) to continue to enhance systems for collecting, processing and reporting data in a timely and efficient way so that study objectives are met; 3) to collaborate with national trial coordinating centers in Australia, Canada, and the United Kingdom which will assist with randomization procedures, data management, and data analysis, and to collaborate with other clinical trial groups on specific studies; and 4) to work closely with all of the organizational groups and committees in the CPCRA to carry out the scientific agenda, and to maintain a SDMC organizational structure and staff that aligns with the larger CPCRA organization and provides a stimulating work atmosphere and peer support.