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

统计和数据管理中心（SDMC）、艾滋病临床试验组（ACTG）

• 批准号: 8975589
• 负责人: Michael David Hughes
• 金额: $ 1365.53万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8975589
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Affect; Biological Assay; Biometry; Chronic; Clinical; Clinical Management; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Communication; Communities; Comorbidity; Data; Development; Diagnosis; Disease; Endpoint Determination; Ensure; Evaluation; Foundations; Funding; Genomics; Guidelines; HIV; HIV-1; Hepatitis; Hospitals; Immunology; Individual; Infection; International; Intervention; Laboratories; Laboratory Study; Leadership; Malignant Neoplasms; Monitor; Mono-S; Morbidity - disease rate; Multi-Drug Resistance; Occupational activity of managing finances; Opportunistic Infections; Pathogenesis; Patients; Pharmacology; Prevention; Protocols documentation; Reporting; Research; Research Personnel; Resources; Safety; Schools; Science; Security; Site; Specific qualifier value; Statistical Data Interpretation; Structure; System; Technology; Testing; Therapeutic; Training; Treatment Protocols; Tuberculosis; United States; Viral hepatitis; Virus Diseases; Woman; Work; base; burden of illness; data integrity; data management; design; electronic data; frontier; health data; high standard; immune activation; improved; innovation; insight; medical specialties; mortality; novel; operation; prevent; protocol development; social; statistics; virology

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.

描述（由申请人提供）：过去 30 年来，人类免疫缺陷病毒 (HIV) 和与获得性免疫缺陷综合症 (AIDS) 相关的机会性感染 (01) 的治疗取得了巨大进步，导致全世界与艾滋病相关的发病率和死亡率大幅下降。 25 年来，艾滋病临床试验小组 (ACTG) 一直走在这些努力的最前沿。 ACTG 进行的临床试验和实验室研究产生了重要见解，构成了当前 HIV-1 感染及其合并症和并发症临床管理指南和标准的基石。尽管取得了这一令人印象深刻的进展，但艾滋病毒治疗的关键方面仍然存在巨大挑战。其中包括： 根除艾滋病毒或实现功能性治愈的策略；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（MDR）结核病；开发更有效和更好耐受的治疗方案来治疗合并感染和单一感染患者的病毒性肝炎；减少治疗慢性艾滋病毒感染时伴随的持续免疫激活，并预防相关的并发症；制定针对艾滋病毒的新型干预措施；改善艾滋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，该议程吸引了一个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性临床试验，这将显着减轻全球艾滋病毒、结核病和肝炎造成的疾病负担。 ACTG 网络领导小组 (LG) 的具体目标包括： 1. ACTG 领导和运营中心 (LOC)。建议新改组的 LOC 为 ACTG 提供科学领导以及财政和组织管理。 ACTG 执行委员会 (AEC) 将作为该网络的总体管理机构。变革科学小组将监督 ACTG 研究议程的制定和执行，该议程将由科学议程指导委员会 (SASC) 进行协调和优先排序。 Social & Scientific Systems, Inc. 的网络协调中心将促进协议的制定、实施、培训和网络评估。布莱根妇女医院 (BWH) 的 LOC 财务管理小组将在 AEC 的指导下监督资源管理和协议资金分配。 LOC 将确保社区参与 ACTG 的各个方面，并将协调网络所有三个组成部分之间的通信。 2. ACTG 实验室中心（LC）。 ACTG LC 将包括病毒学专业实验室、 免疫学、药理学、分枝杆菌学和基因组学能够执行协议指定的测试，并通过开发新的检测方法来解决 ACTG 临床试验中出现的基于创新发病机制的问题，从而推进最先进的技术。 LC 还将监督所有进行临床监测和主要终点确定测试的实验室的质量管理。 LC 领导层将完全融入 LOC 的科学委员会和治理结构，确保 LC 活动与整个网络的研究议程紧密结合。将特别重视在资源有限的国际地点建设网络实验室能力。 3. ACTG 统计和数据管理中心（SDMC）。 SDMC 将包括哈佛大学公共卫生学院 (HSPH) 生物统计和艾滋病研究中心 (CBAR) 的统计和数据分析中心 (SDAC) 以及纽约州阿默斯特前沿科学技术研究基金会 (FSTRF) 的数据管理中心 (DMC)。 SDMC 将为 ACTG 临床试验和实验室研究的设计和生物统计分析提供创新方法；引导准确收集方案特定的临床和实验室数据 通过电子数据采集；确保数据完整性、安全性和质量；并为现场和实验室提供培训。 SDMC 将准备定期报告，以支持数据监测委员会监督 ACTG 试验安全性的工作。 SDMC 的领导层将完全融入 LOC 的科学委员会和治理结构，确保 SDMC 的活动与整个网络的研究议程紧密结合。 相关性：SDMC 提供的专业知识将有助于推进有关治疗 HIV 感染者或影响这些人的结核病和肝炎等疾病的研究。它将通过确保 ACTG 临床试验和其他研究按照最高标准进行有效设计和分析来实现这一目标。这项研究将继续为美国和国际上推进艾滋病毒感染者的最佳治疗做出重大贡献。