SDMC: HIV Prevention Trials Network

描述(由申请人提供)：这份申请继续作为艾滋病毒预防试验网络(HPTN)的统计和数据管理中心(SDMC)，是HPTN领导小组响应RFA-AI-12-011：预防艾滋病毒感染综合战略临床研究网络领导小组(UMI)的三个相互关联的申请中的第三个。HPTN的科学议程集中在以下两个调查领域：1)预防艾滋病毒感染的综合战略和2)扩大更有希望的暴露前预防(PrEP)药物和药物方案的视野。本申请描述了SDMC将如何实现RFA中描述的职责，(I)确保研究设计、数据管理、数据分析的完整性，并酌情遵守法规要求；(Ii)为网络提供有效的数据通信系统；(Iii)为网络附属的CTU/CRSS调查人员和实验室工作人员提供数据管理培训；(Iv)标准化和协调网络内以及必要时与NIH支持的其他网络或其他联邦和私营部门临床试验计划的统计和数据管理活动；以及(Vi)根据 临床数据交换标准联盟(C-DISC)要求的标准。 HPTN SDMC在全球预防研究的设计、实施和分析方面拥有丰富的经验。参与HPTN SDMC的教职员工的科学领导将确保HPTN试验旨在为预防科学领域最紧迫的问题获得可靠的答案。为了帮助指导制定和测试艾滋病毒预防综合战略的复杂任务，我们将参与一个数学建模的合作项目。新的PrEP药物将通过1期、2期和3期试验顺序开发。我们的数据收集、管理、监测和分析系统都经过了良好的测试，并符合非物质文化遗产准则。我们将扩大我们的数据收集工具，将电子移动设备包括在内，以促进对社区和实时行为数据的评估。我们将支持领导小组在完成研究的整个后续行动中快速、准确地报告HPTN研究。我们将通过协调标本和化验结果，以及统计分析和方法开发，继续支持HPTN LC计划。SCARP统计学家将开发和部署统计方法，以提高拟议的艾滋病毒预防试验计划的效率和严谨性。

DESCRIPTION (provided by applicant): This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is the third of three linked applications comprising the Leadership Group of the HPTN in response to RFA-AI-12-011: Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV infection (UMI). The HPTN scientific agenda focuses on the following two areas of inquiry: 1) integrated strategies to prevent HIV infection and 2) expanding horizons for more promising pre-exposure prophylaxis (PrEP) drugs and drug regimens. This application describes how the SDMC will achieve the responsibilities described in the RFA, (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate; (ii) providing effective data communication systems for the network; (iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff; (iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other Federal and private sector clinical trial programs when required; and, (vi) collecting and storing data in accordance with standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements. The HPTN SDMC has extensive experience in the design, conduct and analysis of global prevention studies. The scientific leadership of the faculty engaged in the HPTN SDMC will ensure HPTN trials are designed to obtain reliable answers to the most pressing questions in the prevention science field. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New PrEP drugs will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will expand our data collection tools to include electronic mobile devices to facilitate assessment of communities and real-time behavioral data. We will support the leadership group with rapid, accurate reporting of HPTN studies throughout follow-up to study completion. We will continue to support the HPTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of HIV prevention trials.