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

适应出COVID是评估研究的安全性和有效性的主方案 治疗有症状的非住院成人SARS-CoV-2的药物 感染。它包括第二阶段评估，无缝过渡到更大的阶段 III对前景看好的代理商的评估。 该试验是一个随机的受控平台，允许添加和删除药物 在针对安慰剂的新药物有效测试的研究过程中 相同的试验基础设施。当同时测试多个新代理时， 如果可行，将使用相同的安慰剂。 第二阶段评估的主要结果指标将是症状持续时间， 与门诊流感研究的结果类似，SARS-CoV-2的检测 鼻咽部(NP)拭子RNA，安全性高。确定一个第二阶段是否 代理商将继续在第三阶段进行评估，最后一名参与者将在此之后进行 随机服用该制剂或安慰剂的患者完成第28天的第二阶段治疗。如果继续下去， 从第二阶段登记的参与者收集的数据将包括在第三阶段 评估。 第三阶段评估是第二阶段试验的继续，适用于符合以下条件的代理 进一步评估的标准，以及可获得足够研究产品的标准。招生 其中进入第三阶段的药物将继续进行全功率试验，以确定 每种研究药物与安慰剂在预防住院方面的疗效比较 未住院的成年新冠肺炎患者死亡。 1.ACTG领导和运营中心(LOC)。建议成立一个新重组的劳资关系委员会，以提供委员会的科学领导以及财政和组织管理。反恐执行委员会(AEC)将作为该网络的最高管理机构。变革性科学小组将监督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)协调和优先处理。协议的制定、实施、培训和网络评估将由社会与科学系统公司的网络协调中心提供便利。布里格姆妇女医院(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的分配。LOC将确保社区参与ACTG的所有方面，并将协调网络的所有三个组成部分之间的沟通。 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具备执行特定方案测试的能力，并通过开发新的分析方法来推进最先进的技术，以解决ACTG临床试验中出现的创新的基于发病机制的问题。该委员会还将监督所有为临床监测和主要终点确定进行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密切一致。将特别强调在资源有限的情况下在国际地点建设网络实验室的能力。 3.统计数据管理中心(SDMC)。该中心将由哈佛大学公共卫生学院生物统计和艾滋病研究中心(CBAR)的统计和数据分析中心(SDAC)和纽约阿默斯特前沿科技研究基金会(FSTRF)的数据管理中心(DMC)组成。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的方法；领导准确收集特定方案的临床和实验室数据 通过电子数据采集；确保数据的完整性、安全性和质量；并向各地点和实验室提供培训。国家药品监督管理委员会将编制定期报告，以支持监督ACTG试验安全性的数据监测委员会的工作。国家海洋学委员会的领导将完全融入LOC的科学委员会和治理结构，确保国家海洋学委员会的活动与整个网络的研究议程密切一致。 相关性：国家疾病控制和预防中心提供的专业知识将有助于推动有关艾滋病毒感染者的治疗或影响这些人的结核病和肝炎等疾病的治疗研究。它将通过确保ACTG临床试验和其他研究以最高标准有效地设计和分析来实现这一目标。这项研究将继续为推动美国和国际上艾滋病毒感染者的最佳治疗作出重大贡献。

Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with SARS-CoV-2 infection. It includes a Phase II evaluation, with a seamless transition into a larger Phase III evaluation for promising agents. The trial is a randomized, controlled platform that allows agents to be added and dropped during the course of the study for efficient testing of new agents against placebo within the same trial infrastructure. When more than one new agent is being tested concurrently, the same placebo will be used, when feasible. The primary outcome measures in the Phase II evaluation will be duration of symptoms, similar to the outcome used for outpatient influenza studies, detection of SARS-CoV-2 RNA by nasopharyngeal (NP) swab, and safety. Determination of whether a Phase II agent will continue to be evaluation in Phase III will be made after the last participant randomized to that agent or placebo completes their day 28 Phase II visit. If continued, data collected from participants enrolled in Phase II will be included in the Phase III evaluation. The Phase III evaluation is a continuation of the Phase II trial, for those agents that meet criteria for further evaluation and for which sufficient study product is available. Enrollment of those agents advancing to Phase III will continue for a fully powered trial to determine the efficacy of each investigational agent compared to placebo to prevent hospitalization and death in non-hospitalized adults with COVID-19. 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.