International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

简介(来自申请者摘要)：Insight的使命是开发优化治疗的战略--抗逆转录病毒疗法(ART)、免疫调节疗法以及预防和治疗艾滋病毒和ART并发症的干预措施--以延长人口统计学、社会经济和地理多样性的艾滋病毒感染者群体的无病存活率。具体的研究重点将是“优化临床管理，包括合并症”，其特点是：1)具有发病率和死亡率结果的大型随机试验，在适当的情况下，先锋研究以改进设计参数；2)与资源丰富和资源贫乏的国家相关的研究；3)旨在将长期治疗的不利影响降至最低的研究，同时使益处最大化；4)强调共同纳入的研究，以便在后续队列中可以解决一个以上的主要研究问题；5)作为更大试验的一部分的机械学分研究；6)精心规划的流行病学分析，包括利用大型交叉研究数据库和相关标本储存库的嵌套病例对照研究；以及7)与其他网络建立联系，以最大限度地提高效率和研究生产力。Insight将在35个国家和地区的大约400个地点进行5到6个大型试验。通过精心制定的、具有成本效益的组织计划，强调重要原则-随机化、临床相关干预、出色的随访和集中裁决的结果，以及国际和本地数据质量保证责任的分配-将汇集高质量的数据集，以解决重要的临床管理问题。洞察力协调和业务研究中心(CORE)将设在明尼苏达大学公共卫生学院生物统计部生物识别研究协调中心。核心中心与网络实验室以及统计和数据管理中心设在同一地点，将利用精简的组织结构以及大学的行政支助、资源和服务。多个网络地点没有独立的、重复的行政职能，消除了相关的增量成本，促进了一个反应更迅速、更统一的网络，将最少的时间投入到网络组成部分的活动协调上，并建立在通过合并基本活动和共享资源可以实现的规模经济的基础上。

Description (from applicant Abstract): INSIGHT'S mission is to develop strategies for the optimization of treatment -- antiretroviral therapies (ART), immunomodulatory therapies, and interventions to prevent and treat complications of HIV and ART - in order to prolong disease-free survival in a demographically, socio-economically, and geographically diverse population of individuals infected with HIV. The specific research emphasis will be "optimization of clinical management, including co-morbidities," and will be characterized by 1) Large randomized trials with morbidity and mortality outcomes, and where appropriate preceded by vanguard studies to refine design parameters; 2) Studies relevant to both resource-rich and resource-poor countries; 3) Studies directed at minimizing the adverse effects of long-term treatment while maximizing the benefits; 4) Studies emphasizing co-enrollment so that more than one major research question can be addressed in the cohorts under followup; 5) Mechanistic substudies as part of larger trials; 6) Carefully planned epidemiological analyses, including nested case-control studies that take advantage of a large cross-study database and associated specimen repository; and 7) Linkages with other networks to maximize efficiency and research productivity. INSIGHT will conduct 5 or 6 large trials at approximately 400 sites in 35 countries. Through a carefully developed, cost efficient, organizational plan that emphasizes important principles - randomization, clinically relevant interventions, excellent follow-up, and centrally adjudicated outcomes, and distribution of responsibilities for international and local data quality assurance - high-quality data sets will be assembled to address important clinical management questions. The INSIGHT Coordinating and Operations Research Center (CORE) will be located at the Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, at the University of Minnesota. The CORE, co-located with the Network Laboratory and Statistical and Data Management Center, will take advantage of a streamlined organizational structure and the administrative support, resources, and services of the University. The absence of stand-alone, duplicative administrative functions at multiple network locations eliminates the related incremental costs, fosters a more responsive and unified network with minimal time invested in the coordination of activities by network components, and builds on the economies of scale that can be realized by combining essential activities and sharing resources.