Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)

描述（由申请人提供）：在过去30年中，在治疗人类免疫缺陷病毒（HIV）和与获得性免疫缺陷综合征（AIDS）相关的机会性感染（01）方面取得了巨大进展，导致全世界与艾滋病相关的发病率和死亡率大幅下降。艾滋病临床试验小组（ACTG）已经在这些努力的最前沿超过25年。ACTG进行的临床试验和实验室研究产生了重要见解，这些见解构成了目前艾滋病毒-1感染及其合并症和并发症临床管理指南和标准的基石。尽管取得了令人印象深刻的进展，但在艾滋病毒治疗的关键方面仍然存在重大挑战。这些战略包括：根除艾滋病毒或实现功能性治愈的战略；结核病的诊断、治疗和预防，包括合并感染和单一感染患者的耐多药结核病；为合并感染和单一感染的病毒性肝炎患者制定更有效和耐受性更好的治疗方案；减少伴随经治疗的慢性艾滋病毒感染的持续免疫激活，并预防相关的合并症；开发针对艾滋病毒的新干预措施；提高对乙型肝炎病毒相关恶性肿瘤的诊断、治疗和预防。ACTG提出了一项全面的研究议程，利用由领先的临床和实验室艾滋病毒研究人员组成的国际联盟，与世界一流的统计和数据管理中心合作，设计和开展创新的介入临床试验，以显着减少由艾滋病毒、结核病和肝炎引起的疾病的全球负担。ACTG网络领导小组的具体目标包括：

DESCRIPTION (provided by applicant): Great strides have been made in the treatment of human immunodeficiency virus (HIV) and the opportunistic infections (01) associated with acquired immune deficiency syndrome (AIDS) over the last 30 years, resulting in substantial reductions in AIDS associated morbidity and mortality throughout the world. The AIDS Clinical Trials Group (ACTG) has been at the forefront of these efforts for more than 25 years. Clinical trials and laboratory studies conducted by the ACTG have produced major insights that form the cornerstones of current guidelines and standards of clinical management of HIV-1 infection and its co-morbidities and complications. Despite this impressive progress, substantial challenges remain in key aspects of HIV therapeutics. These include: strategies for eradicating HIV or achieving functional cure; diagnosis, treatment and prevention of tuberculosis, including multidrug-resistant (MDR) TB in co-infected and mono-infected patients; developing more effective and better tolerated regimens for the treatment of viral hepatitis in co-infected and monoinfected patients; reducing the persistent immune activation that accompanies treated chronic HIV infection and preventing the associated co-morbidities; developing novel interventions targeting HIV; and improving the diagnosis, treatment and prevention of HlV-associated malignancies. The ACTG proposes a comprehensive research agenda that draws on an international consortium of leading clinical and laboratory HIV investigators in collaboration with a world-class Statistics and Data Management Center to design and conduct innovative interventional clinical trials that will significantly reduce the global burden of diseae due to HIV, TB and hepatitis. Specific aims of the ACTG Network Leadership Group (LG) include: 1. The ACTG Leadership and Operations Center (LOC). A newly restructured LOC is proposed to provide scientific leadership and fiscal and organizational management of the ACTG. The ACTG Executive Committee (AEC) will serve as the overarching governing body of the network. Transformative Science Groups will oversee the development and execution of the ACTG research agenda, which will be coordinated and prioritized by the Scientific Agenda Steering Committee (SASC). Protocol development, implementation, training and network evaluation will be facilitated by the Network Coordinating Center at Social & Scientific Systems, Inc. The LOC financial management group at Brigham and Women's Hospital (BWH) will oversee resource management and protocol fund distribution at the direction of the AEC. The LOC will assure the engagement of Community in all aspects of the ACTG, and will coordinate communication between all three components of the network. 2. The ACTG Laboratory Center (LC). The ACTG LC will comprise Specialty Laboratories in virology, immunology, pharmacology, mycobacteriology and genomics equipped to perform protocol-specified testing and to advance the state-of-the-art by developing novel assays to address innovative pathogenesis-based questions arising from ACTG clinical trials. The LC will also oversee the quality management of all laboratories performing testing for clinical monitoring and primary endpoint determination. The LC leadership will be fully integrated into the scientific committee and governance structure of the LOC, assuring close alignment of LC activities with the research agenda of the network as a whole. Particular emphasis will be placed on building network laboratory capacity at international sites in resource-limited settings. 3. The ACTG Statistics and Data Management Center (SDMC). The SDMC will comprise the Statistical and Data Analysis Center (SDAC) at the Center for Biostatistics and AIDS Research (CBAR) at Harvard School of Public Health (HSPH) and the Data Management Center (DMC) at Frontier Science & Technology Research Foundation (FSTRF) in Amherst, NY. The SDMC will provide innovative approaches to the design and biostatistical analysis of ACTG clinical trials and laboratory studies; leads accurate collection of protocol specific clinical and laboratory data through electronic data capture; ensure data integrity, security and quality; and provide training to sites and laboratories. The SDMC will prepare regular reports to support the work of data monitoring committees overseeing the safety of ACTG trials. The SDMC leadership will be fully integrated into the scientific committee and governance structure of the LOC, assuring close alignment of SDMC activities with the research agenda of the network as a whole. RELEVANCE: The expertise provided by the SDMC will help advance research concerning the treatment of HIV-infected people or of diseases such as tuberculosis and hepatitis affecting these people. It will achieve this by ensuring that ACTG clinical trials and other studies are efficiently designed and analyzed to the highest standards. This research will continue to make significant contributions in advancing optimal treatment of HIV-infected individuals both in the Unites States and internationally.