Center/Coordination, Analysis and Management/MACS

中心/协调、分析与管理/MACS

• 批准号: 8072924
• 负责人: LISA P JACOBSON
• 金额: $ 13.66万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-07 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8072924
• 关键词: Center; Coordination; Analysis; Management; MACS

DESCRIPTION (provided by applicant): The Multicenter AIDS Cohort Study (MACS), a comprehensive cohort study ongoing since 1984, has contributed to the understanding of the natural history of HIV infection and the impact of highly active antiretroviral therapies (HAART). Combining genetic, virologic, immunologic and psychosocial approaches and utilizing the repository of specimens and long-term characterization of the participants, the extension of the support of the MACS will allow further elucidation of the biology of and response to HIV infection in the absence and presence of therapies, and distinguishing the effects of age, HIV and HAART on clinical outcomes. The MACS is ideally positioned to address these issues because of long-term standardized follow-up of 6,972 men, an extensive specimen repository and an appropriate control group consisting of HIV uninfected men with similar lifestyle behaviors and demographics. Additional strengths include following over 653 men before and after infection and with known dates of infection, experienced investigators and a broad network of outstanding collaborators with expertise in all aspects of HIV disease. This application further seeks support for the extension of the Center for the Analysis and Management of the MACS Data (CAMACS) to provide epidemiologic and statistical leadership to the MACS research agenda. The multicenter collaborative aspect, the complexities of characterizing the balance between beneficial and adverse effects of therapies, the selective use of treatment and the challenges inherent in choosing efficient study designs appropriate to the research questions require an analytical center to integrate HIV science with expertise in epidemiology, statistics and data management for MACS to successfully address the scientific aims as stated in Part A of this application. The specific aims of CAMACS are to provide leadership and quality-assured systems to: 1) coordinate the research initiatives (includes effective communication, study protocol and form revision, periodic presentation of statistical characterizations pertinent to the scientific agenda); 2) manage the data to facilitate analyses (includes edit, documentation, storage, and dissemination); 3) provide statistical and epidemiological expertise in the design, analysis and interpretation of studies and to develop statistical and epidemiologic methodology; and 4) promote and track the use of MACS data/specimens. RELEVANCE: The scientific partnership and methods implemented by CAMACS will allow MACS to answer important questions relevant to treated HIV populations, and to understand the biology of treated and untreated HIV infection. This research may contribute to prevention of infection, provide insights relevant to the development of effective vaccines for HIV, and provide information to enhance the survival and quality of extended life

描述（由申请人提供）： 多中心艾滋病队列研究（MACS）是一项自1984年以来进行的综合性队列研究，有助于了解艾滋病毒感染的自然史和高效抗逆转录病毒疗法（HAART）的影响。结合遗传学、病毒学、免疫学和心理社会学方法，并利用标本库和参与者的长期特征，MACS支持的扩展将允许进一步阐明在没有和存在治疗的情况下艾滋病毒感染的生物学和反应，并区分年龄、艾滋病毒和HAART对临床结果的影响。MACS是解决这些问题的理想选择，因为它对6，972名男性进行了长期标准化随访，拥有广泛的标本库，并有一个由具有相似生活方式和人口统计学特征的未感染HIV的男性组成的适当对照组。其他优势包括在感染前后和感染日期已知的653名男子，经验丰富的调查人员和在艾滋病毒疾病的各个方面具有专业知识的杰出合作者的广泛网络。该申请进一步寻求对MACS数据分析和管理中心（CAMACS）扩展的支持，以提供流行病学和统计领导MACS研究议程。多中心合作方面，描述治疗的有益和不良影响之间的平衡的复杂性，选择性使用治疗以及选择适合研究问题的有效研究设计所固有的挑战，需要一个分析中心将艾滋病毒科学与流行病学专业知识相结合，MACS的统计和数据管理，以成功实现本申请A部分所述的科学目标。CAMACS的具体目标是提供领导和质量保证系统，以：1）协调研究活动（包括有效的沟通、研究方案和表格修订、定期提交与科学议程有关的统计特征）; 2）管理数据以促进分析（包括编辑、记录、存储和传播）; 3）在设计中提供统计和流行病学专门知识，分析和解释研究，并制定统计和流行病学方法;以及4）促进和跟踪MACS数据/标本的使用。 相关性：CAMACS实施的科学伙伴关系和方法将使MACS能够回答与接受治疗的艾滋病毒人群相关的重要问题，并了解接受治疗和未接受治疗的艾滋病毒感染的生物学。这项研究可能有助于预防感染，为开发有效的艾滋病毒疫苗提供相关见解，并为提高延长寿命的生存率和质量提供信息。