SDMC; Statistical Data Mgmt Core

SDMC；

基本信息

批准号：
10595908
负责人：
Kathryn E Muessig
金额：
$ 358.05万
依托单位：
FLORIDA STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-01-25 至 2029-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10595908
关键词：
AIDS prevention Acquired Immunodeficiency Syndrome Address Adolescent Medicine Trials Network Adolescent and Young Adult Biometry Caring Clinical Clinical Research Clinical Trials Collaborations Communities Cost Analysis Data Data Analyses Data Collection Data Security Enrollment Ensure Epidemic Epidemiologic Monitoring Epidemiology Equity Ethical Review Evaluation Evidence based intervention Foundations Funding Future Guidelines HIV HIV risk HIV-infected adolescents HIV/AIDS Human Human immunodeficiency virus test Individual Information Systems Institution International Intervention Intervention Studies Laboratories Lead Leadership Management Information Systems Medical Mentorship Modeling North Carolina Pathway Analysis Persons Policies Positioning Attribute Prevention Protocols documentation Provider Public Health Publications Reproducibility Request for Applications Research Research Design Research Personnel Research Project Grants Research Support Resources Risk Science Secure Services Site Standardization Statistical Data Interpretation Statistical Methods Statistical Models Supervision System Technology Time Underrepresented Minority United States United States National Institutes of Health Universities Work Youth adolescent HIV prevention behavioral clinical trial care outcomes clinical care clinical practice data access data dissemination data harmonization data management epidemiological model evidence base experience improved innovation mathematical model programs research study therapy development

项目摘要

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.

项目概要作为一个成熟的研究网络，ATN 已准备好聚集创新且经验丰富的学者，能够正确提供预防和治疗技术的提供者和社区合作伙伴在正确的时间和地点进行组合，让那些最能受益的人受益。强大的统计和数据管理核心 (SDMC) 是成功规划、实施、分析、传播和管理的核心。管理所有 ATN 研究项目、跨网络分析以及对青少年领域的贡献和青年艾滋病毒预防和护理。为了为本次 ATN 融资周期提供 SDMC 服务，我们组建了来自北卡罗来纳大学埃姆斯分校和哈佛大学/麻省总医院的领导团队。这 SDMC将为所有网络临床研究提供全面的数据管理和分析；领导; 以及监管方面、生物统计学、研究设计、分析、解释和结果发布的服务。 SDMC 将使用创新的统计方法和最先进的临床试验管理系统，实验室信息管理系统确保数据完整、高质量。 SDMC领导统一致力于通过卓越的循证干预措施改善艾滋病毒预防和护理结果研究。我们的核心将提供科学和分析专业知识、全面的数据管理和数据对 ATN 及其个人和跨网络的管理资源、协调和监督协议以及更广泛的科学和 ATN 利益相关者社区。 SDMC 负责研究设计的完整性、数据管理的质量以及所有临床分析的严谨性和可重复性本申请中提出的研究以及本 ATN 项目周期内未来出现的科学优先事项。我们将确保所有 ATN 研究符合机构伦理审查定义的数据访问和安全协议要求、联邦监管标准和适用的国际准则。此外，SDMC 将领导 ATN 内数据管理和统计活动的标准化和协调工作与其他 NIH 资助的项目。在单个研究的整个生命周期中，SDMC 将协调支持临床和实验室数据收集和管理所需的服务和系统研究项目和 ATN 总体研究议程。在这些活动中，SDMC 将有意通过指导和参与，促进更公平地使用、获取和传播数据 SDMC 活动中的受训人员、早期研究人员和代表性不足的少数群体。我们组装了一个多元化的团队，在统计分析、流行病学方面具有互补的领导经验和专业知识艾滋病毒、统计模型和成本分析、青少年和年轻人艾滋病毒干预措施的制定和评估、循证临床护理、网络科学以及多地点、多研究生物医学和行为临床试验。我们的 SDMC 领导模型和集体专业知识将提供高质量的研究设计、数据系统和管理以及数据管理，以产生有影响力的科学，以减少青少年艾滋病毒。