SDMC: HIV Prevention Trials Network

项目总结/摘要 RFA-AI-19-002的本申请将继续作为统计和数据管理中心（SDMC）， 艾滋病毒预防试验网络。HPTN的首要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，以满足 美国和世界各地。HPTN将通过以下方式实现这一目标：1）新的生物医学产品， 具有独特特征的艾滋病毒预防工具，如作用时间更长，艾滋病毒的新目标 抑制或作为多用途技术; 2）优化使用已证明有效的 针对特定高危人群的预防干预措施，以实现最大的公共卫生影响。 HPTN SDMC位于西雅图的Fred哈钦森癌症研究中心，并利用 该机构的特殊优势，其中还包括HVTN SDMC，以及数据和协调中心 其他几个研究网络。HPTN SDMC拥有设计经验丰富的生物统计学家， 进行和分析全球艾滋病毒预防研究，通过以下方式支持HPTN研究的目标： 领导统计设计、试验开展和分析，以及制定和实施创新的 根据HPTN科学目标的需要和动机使用统计方法。SDMC提供符合法规的 所有HPTN试验的数据管理功能，包括直接从研究中心采集的电子数据， 实验室标本和分析结果的整合，以及电子参与者报告的结果。 在资助期间，SDMC将设计和分析抗逆转录病毒和广泛的1-3期试验。 中和单克隆抗体（bNAb）产品，包括完成两项III期活性对照 长效cabotegravir（CAB LA）的随机临床试验（RCT）和两项III期安慰剂对照RCT bNAb VRC-01的基因SDMC将全力支持多用途技术的开发途径， 包括可接受性和基于用户的设计。如果CAB LA被证明有效，它将被纳入 用于高危人群的综合策略试验。综合策略的试验设计范围从 个体随机化、分组随机化（平行或逐步楔形）、非随机化试验， 取决于环境和人口。数学模型将估算人口影响和成本- 成功的HPTN干预措施在特定风险人群中的有效性。 SDMC将继续提供高质量、及时、具有成本效益和安全的数据管理和安全性 HPTN试验的监测功能。最先进的数据采集、存储、质量控制系统， 管理和注释将符合临床数据交换标准联盟（CDISC）， 采用持续质量改进战略。HPTN社会行为研究得到支持 通过与外部数据源（包括移动的应用程序、短信、平板电脑和 电子患者报告结局。

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.