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

{\fnSimHei\bord1\shad1\pos（200，288）} INSIGHT的使命是开发优化治疗策略--抗逆转录病毒疗法（ART）， 免疫调节疗法，以及预防和治疗HIV和ART并发症的干预措施-按顺序\par 在人口统计学、社会经济学和地理上多样化的环境中延长无病生存期， 艾滋病毒感染者的人数。具体的研究重点将是“优化临床\” 管理，包括共病，”并将通过1）大型随机试验进行表征， 发病率和死亡率结果，并在适当的情况下进行先锋研究，以完善设计 2）与资源丰富和资源贫乏的国家有关的研究; 3）针对资源丰富和资源贫乏的国家的研究; 4）针对资源丰富和资源贫乏的国家的研究。 最大限度地减少长期治疗的副作用，同时最大限度地提高效益; 4）研究强调\par 共同入组，以便在随访队列中解决一个以上的主要研究问题;\par 5)机制子研究作为大型试验的一部分; 6）精心计划的流行病学分析， 包括利用大型交叉研究数据库和相关\par的嵌套病例对照研究 标本库; 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。par INSIGHT将在35个国家的约400个地点进行5或6项大型试验，以全面实施该计划。 强调重要原则的成本效益方法-随机化，临床相关干预，\par 良好的长期随访和集中裁定的临床结局。通过精心开发的\par 组织计划，分配国际和本地数据质量保证、高质量\par 将收集数据集，以解决重要的临床管理问题。经验丰富的\par 调查员、与其他网络的合作以及专门领域顾问的指导， 将对科学文献和医疗实践指南做出大量和及时的贡献。par 这些贡献将推动DAIDS的使命，以促进治疗的进展-发现和\par 艾滋病毒感染及其并发症的治疗方法的发展。par INSIGHT Leadership应用程序包括三个组件：1）协调和研究运营\par 中心（CORE），2）网络实验室（NL）和3）统计和数据管理中心（SDMC）。所有\par 三个组成部分将共同设在生物识别研究协调中心， 明尼苏达大学公共卫生学院生物统计学。fs20\par \参数 }

{\rtf1\ansi\ansicpg1252\deff0\deflang1033{\fonttbl{\f0\fswiss\fcharset0 Arial;}} {\*\generator Msftedit 5.41.15.1515;}\viewkind4\uc1\pard\f0\fs23 INSIGHT'S mission is to develop strategies for the optimization of treatment -- antiretroviral therapies (ART),\par immunomodulatory therapies, and interventions to prevent and treat complications of HIV and ART - in order\par to prolong disease-free survival in a demographically, socio-economically, and geographically diverse\par population of individuals infected with HIV. The specific research emphasis will be "optimization of clinical\par management, including co-morbidities," and will be characterized by 1) Large randomized trials with\par morbidity and mortality outcomes, and where appropriate preceded by vanguard studies to refine design\par parameters; 2) Studies relevant to both resource-rich and resource-poor countries; 3) Studies directed at\par minimizing the adverse effects of long-term treatment while maximizing the benefits; 4) Studies emphasizing\par co-enrollment so that more than one major research question can be addressed in the cohorts under followup;\par 5) Mechanistic substudies as part of larger trials; 6) Carefully planned epidemiological analyses,\par including nested case-control studies that take advantage of a large cross-study database and associated\par specimen repository; and 7) Linkages with other networks to maximize efficiency and research productivity.\par INSIGHT will conduct 5 or 6 large trials at approximately 400 sites in 35 countries, implementing the plan in a\par cost-effective way with emphasis on important principles ~ randomization, clinically relevant interventions,\par excellent long-term follow-up, and centrally adjudicated clinical outcomes. Through a carefully developed\par organizational plan that distributes responsibilities for international and local data quality assurance, highquality\par data sets will be assembled to address important clinical management questions. With experienced\par investigators, collaborations with other networks, and the guidance of consultants in specialized areas,\par substantial and timely contributions will be made to the scientific literature and medical practice guidelines.\par These contributions will advance the DAIDS mission to promote progress in treatment - the discovery and\par development of therapies for HIV infection and its complications.\par The INSIGHT Leadership application includes three components: 1) Coordinating and Research Operations\par Center (CORE), 2) Network Laboratory (NL), and 3) Statistical and Data Management Center (SDMC). All\par three components will be colocated at the Coordinating Centers for Biometric Research, Division of\par Biostatistics, School of Public Health, at the University of Minnesota.\fs20\par \par }