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

INSIGHT的使命是制定治疗优化策略——抗逆转录病毒疗法（ART）、免疫调节疗法和干预措施，以预防和治疗HIV和ART的并发症——以延长人口统计学、社会经济和地理上不同的HIV感染者群体的无病生存期。具体的研究重点将是“临床管理的优化，包括合并症”，其特点将是1)具有发病率和死亡率结果的大型随机试验，并在适当的情况下进行先锋性研究，以完善设计参数；2)资源丰富国家和资源贫乏国家的相关研究；3)旨在使长期治疗的不良反应最小化而使获益最大化的研究；4)强调联合入组的研究，以便在随访队列中解决多个主要研究问题；5)作为大型试验一部分的机制亚研究；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库的巢式病例对照研究；7)与其他网络的联系，以最大限度地提高效率和研究生产力。INSIGHT将在35个国家的约400个地点进行5或6次大型试验。通过精心制定的、具有成本效益的、强调重要原则的组织计划——随机化、临床相关干预措施、优秀的随访、集中裁决的结果，以及国际和本地数据质量保证的责任分配——将收集高质量的数据集，以解决重要的临床管理问题。INSIGHT协调和运营研究中心（CORE）将设在明尼苏达大学公共卫生学院生物统计学系生物识别研究协调中心。该中心与网络实验室和统计与数据管理中心同处一处，将利用大学精简的组织结构、行政支持、资源和服务。在多个网络地点没有独立的、重复的管理职能，消除了相关的增加成本，促进了一个反应更迅速和统一的网络，在协调网络组成部分的活动方面投入的时间最少，并建立了通过合并基本活动和共享资源可以实现的规模经济。

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.