Center/Coordination, Analysis and Management/MACS

中心/协调、分析与管理/MACS

• 批准号: 7638686
• 负责人: LISA P JACOBSON
• 金额: $ 251.09万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7638686
• 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 年以来持续进行的综合队列研究，有助于了解 HIV 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、病毒学、免疫学和心理社会方法，并利用样本库和参与者的长期特征，MACS 的支持范围扩大将有助于进一步阐明在没有或有治疗的情况下 HIV 感染的生物学和反应，并区分年龄、HIV 和 HAART 对临床结果的影响。 MACS 非常适合解决这些问题，因为它对 6,972 名男性进行了长期标准化随访，拥有广泛的样本库和由具有相似生活方式行为和人口统计数据的未感染 HIV 的男性组成的适当对照组。其他优势包括对感染前后超过 653 名已知感染日期的男性进行追踪、经验丰富的调查人员以及在 HIV 疾病各个方面具有专业知识的杰出合作者组成的广泛网络。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，以便为 MACS 研究议程提供流行病学和统计领导力。多中心协作方面、描述治疗有益和不良影响之间平衡的复杂性、治疗的选择性使用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 HIV 科学与 MACS 的流行病学、统计和数据管理专业知识相结合，以成功实现本申请 A 部分中所述的科学目标。 CAMACS 的具体目标是提供领导力和质量保证系统，以： 1) 协调研究举措（包括有效沟通、研究方案和表格修订、定期呈现与科学议程相关的统计特征）； 2) 管理数据以促进分析（包括编辑、记录、存储和传播）； 3) 在研究设计、分析和解释方面提供统计和流行病学专业知识，并制定统计和流行病学方法； 4) 促进和跟踪 MACS 数据/样本的使用。 相关性：CAMACS 实施的科学伙伴关系和方法将使 MACS 能够回答与治疗的 HIV 人群相关的重要问题，并了解治疗和未治疗的 HIV 感染的生物学。这项研究可能有助于预防感染，提供与开发有效的艾滋病毒疫苗相关的见解，并提供提高生存率和延长生命质量的信息