Center/Coordination, Analysis and Management/MACS-Part B

描述(由申请人提供) 这项申请是为了更新多中心艾滋病队列研究分析和管理中心(CAMACS)。MACS是一项正在进行的队列研究，截至2003年6月30日，已有6948名男性在巴尔的摩、芝加哥、洛杉矶和匹兹堡的地点登记参加，该研究对艾滋病毒感染的自然历史做出了重大贡献。多中心协作方面、多个固定队列的登记、MACS所涉及的数据复杂性以及选择性治疗的使用需要一个数据协调中心，以将艾滋病毒科学与流行病学、统计学和数据管理方面的专门知识结合起来，以处理MACS统一提案-A部分中提出的科学议程。CAMACS的具体目标是：1)协调MACS范围内的研究，包括数据获取、定期报告MACS研究人口和数据库的状况、分发用于研究的数据和样本；2)使用既定的程序管理在研究中收集的数据，用于转移、编辑、合并、存储和备份数据；3)与互委会和外部调查人员合作，在设计、分析和解释与研究核心目标有关的研究方面提供统计和流行病学方面的专门知识；以及4)提供基础设施和资源，以促进在艾滋病毒感染的科学研究中使用互委会的数据和标本，并跟踪获批项目的进展情况。CAMACS将继续开发统一提案D.9节中提出的创新方法。CAMACS调查团队在研究协调、系统和数据管理、流行病学和复杂纵向数据和生存分析的生物统计方法方面拥有丰富的专业知识和经验。为方案开发开发的成功方法包括研究设计和功率计算、标准化数据获取、管理和总结以及质量保证，并将继续应用于HAART的代谢和心血管不良事件研究。CAMACS将积极参与研究管理，并作为执行委员会成员、数据工作组主席、每个科学工作组的成员和编写委员会的成员，在监督研究方案、分析和提交研究结果方面发挥领导作用。

DESCRIPTION (provided by applicant) This application is for the renewal of the Center for Analysis and Management of the Multicenter AIDS Cohort Study (CAMACS). The MACS, an ongoing cohort study in which 6948 men have been enrolled as of June 30, 2003 at sites located in Baltimore, Chicago, Los Angeles, and Pittsburgh, has made significant contributions to the natural history of HIV infection. The multicenter collaborative aspects, the enrollment of multiple, fixed cohorts, the data complexity involved in the MACS and the selective use of treatment require a data coordination center to integrate the HIV science with expertise in epidemiology, statistics and data management to address the scientific agenda as set forth in the Unified MACS Proposal - Part A. The specific aims of CAMACS are: 1) to coordinate MACS-wide research, including data acquisition, periodic reporting on the status of the MACS study population and database, and distribution of data and specimens for research; 2) to manage the data collected in the study using established procedures for transferring, editing, merging, storing and backing up the data; and to implement procedures for quality assurance in all aspects; 3) to collaborate with MACS and external investigators by providing statistical and epidemiological expertise in the design, analysis and interpretation of studies related to the core aims of the study; and 4) to provide an infrastructure and resources to promote use of MACS data and specimens in scientific studies of HIV infection and for tracking the progress of approved projects. CAMACS will continue to develop innovative methodology as put forth in section D.9 of the Unified Proposal. The CAMACS investigative team has extensive expertise and experience in research coordination, systems and data management, epidemiology and biostatistical methods for complex longitudinal data and survival analysis. Successful methods developed for protocol development include study design and power computations, standardized data acquisition, management and summarization and quality assurance will be continued and applied to the study of metabolic and cardiovascular adverse events of HAART. CAMACS will actively participate in the study governance and provide leadership in the oversight of study protocols, analyses, and presentation of study results as a member of the Executive Committee, chair of the Data Working Group, membership to each scientific Working Group, and in writing committees.