SDMC; Statistical Data Mgmt Core

点击翻译按钮获取中文摘要

PROJECT SUMMARY As a mature research network, the ATN is well-poised to assemble innovative and experienced scholars, providers and community partners that can deliver prevention and treatment technologies in the right combinations at the right time and place for those who could benefit most. A strong Statistical and Data Management Core (SDMC) is central to the successful planning, implementation, analysis, dissemination, and stewardship of all ATN research projects, cross-network analyses, and contributions to the field of adolescent and young adult HIV prevention and care. To provide SDMC services for this ATN funding cycle, we assembled a leadership team from the University of North Carolina, Emmes, and Harvard University/Mass General. The SDMC will provide comprehensive data management and analyses for all network clinical studies; leadership; and services for regulatory aspects, biostatistics, study design, analysis, interpretation, and publication of results. The SDMC will use innovative statistical methods and state-of-the-art clinical trial management systems and laboratory information management systems to ensure complete, high-quality data. SDMC leaders are uniformly committed to improving HIV prevention and care outcomes through excellence in evidence-based interventional research. Our Core will provide scientific and analytic expertise, comprehensive data management and data stewardship resources, and coordination, and supervision to the ATN and its individual and cross-network protocols, as well as to the broader scientific and ATN stakeholder communities. The SDMC is responsible for the integrity of study design, quality of data management and rigor and reproducibility of analyses for all clinical studies proposed in this application and future emerging scientific priorities during this ATN project cycle. We will ensure that all ATN studies meet data access and security protocols defined by institutional ethical review requirements, federal regulatory standards, and applicable international guidelines. In addition, the SDMC will lead efforts to standardize and harmonize data management and statistical activities within the ATN and in line with other NIH-sponsored programs. Throughout the lifetime of an individual study, the SDMC will coordinate services and systems for the clinical and laboratory data collection and management required to support the research projects and the overall ATN research agenda. Across these activities, the SDMC will intentionally promote more equitable use, accessibility, and dissemination of data through mentorship and involvement of trainees, early-stage investigators, and under-represented minorities in SDMC activities. We have assembled a diverse team with complementary leadership experience and expertise in statistical analyses, epidemiology of HIV, statistical modeling and cost analysis, adolescent and young adult HIV intervention development and evaluation, evidence-based clinical care, network science and multi-site, multi-study biomedical and behavioral clinical trials. Our SDMC leadership model and collective expertise will provide the high-quality study design, data systems and management, and data stewardship to generate impactful science to reduce adolescent HIV.