SDMC: HIV Prevention Trials Network

项目摘要/摘要 这项对RFA-AI-19-002的申请将继续作为 艾滋病毒预防试验网络(HPTN)。HPTN的总体目标是确定可接受的、可行的、 安全、有效和可扩展的艾滋病毒预防干预措施，满足 我们和世界各地。HPTN将通过以下方式解决这一目标：1)新的生物医学产品和 具有独特特点的艾滋病毒预防工具，如更长的行动期限、艾滋病毒的新目标 抑制或作为多用途技术；2)优化使用已证实有效的综合战略 针对处于危险中的特定人群量身定做的预防措施，以实现最大的公共卫生影响。 HPTN SDMC设在西雅图的弗雷德·哈钦森癌症研究中心，利用 该机构的独特优势还包括HVTN SDMC以及数据和协调中心 为其他几个研究网络服务。HPTN SDMC拥有在设计方面经验丰富的生物统计师， 开展和分析全球艾滋病毒预防研究，世卫组织通过以下途径支持HPTN研究的目标 在统计设计、试验进行和分析以及创新的开发和实施方面发挥领导作用 HPTN科学目标所需和激励的统计方法。国家工商行政管理委员会提供合规的 所有HPTN试验的数据管理功能，包括直接从研究网站获取电子数据， 综合实验室样本和化验结果，以及电子参与者报告的结果。 在赠款期间，国家药品监督管理委员会将设计和分析抗逆转录病毒和广泛的1-3阶段试验。 中和单抗(BNAb)产品，包括完成两个阶段3主动控制 长效卡替格雷(CAB LA)和两个3期安慰剂对照随机临床试验(RCT) BNAb VRC-01。国家计委将全力支持多用途技术的发展道路， 包括可接受性和以用户为基础的设计。如果CAB LA被证明有效，它将被合并 纳入针对高危人群的综合战略试验。综合战略的试验设计将包括 从个体随机化到整群随机化(平行或阶梯式)，再到非随机化试验， 这取决于背景和人口。数学建模将估计人口影响和成本- 成功的HPTN干预措施在特定高危人群中的有效性。 国家数据中心将继续提供高质量、及时、经济高效和安全的数据管理和安全 HPTN试验的监控功能。最先进的数据采集、存储、质量控制、 管理和注释将符合临床数据交换标准联盟(CDISC)和 使用持续的质量改进策略进行维护。支持HPTN社会行为研究 通过灵活的数据接口流程与外部数据源(包括移动应用、短信、平板电脑和 电子患者报告结果。

PROJECT SUMMARY/ABSTRACT This application to RFA-AI-19-002 is to continue as the statistical and data management center (SDMC) for the HIV Prevention Trials Network (HPTN). The overarching goal of the HPTN is to identify acceptable, feasible, safe, effective, and scalable interventions for HIV prevention that address the needs of populations at risk in the US and around the world. The HPTN will address this goal through identifying: 1) new biomedical products and tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets of HIV inhibition or as multi-purpose technologies; 2) integrated strategies that optimize use of proven efficacious prevention interventions tailored to specific populations at risk to achieve maximal public health impact. The HPTN SDMC is housed at the Fred Hutchinson Cancer Research Center in Seattle and takes advantage of the particular strengths of the institution, which also includes the HVTN SDMC, and data and coordinating centers for several other research networks. The HPTN SDMC has faculty biostatisticians experienced in the design, conduct and analysis of global HIV prevention studies, who support the goals of HPTN research through leadership in statistical design, trial conduct and analysis, and development and implementation of innovative statistical methods as needed and motivated by HPTN scientific goals. The SDMC provides regulatory compliant data management functions for all HPTN trials, including electronic data capture directly from research sites, integration of laboratory specimens and assay results, and electronic participant reported outcomes. During the grant period, the SDMC will design and analyze Phase 1-3 trials of both antiretroviral and broadly neutralizing monoclonal antibody (bNAb) products, including completion of two Phase 3 active-controlled randomized clinical trials (RCTs) of long-acting cabotegravir (CAB LA) and two Phase 3 placebo-controlled RCTs of the bNAb VRC-01. The SDMC will fully support the development pathway for multi-purpose technologies, encompassing both acceptability and user-based design. If CAB LA proves efficacious, it will be incorporated into integrated strategy trials for populations at risk. Trial designs for integrated strategies will range from individual-randomized, to cluster-randomized (either parallel or step-wedge), to non-randomized trials, depending on the context and population. Mathematical modeling will estimate the population impact and cost- effectiveness of successful HPTN interventions in specific populations at risk. The SDMC will continue to deliver high-quality, timely, cost-efficient, and secure data management and safety monitoring functions for HPTN trials. State-of-the-art systems for data acquisition, storage, quality control, curation, and annotation, will be compliant with Clinical Data Interchange Standards Consortium (CDISC) and maintained using a continuous quality improvement strategy. HPTN socio-behavioral research is supported through flexible data interface processes with external data sources including mobile apps, SMS, tablets, and electronic Patient Reported Outcomes.