SDMC; Statistical Data Mgmt Core

SDMC；

• 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
• 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

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.

项目总结 作为一个成熟的研究网络，ATN已经做好了聚集创新和经验丰富的学者的准备， 能够适当地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，让那些可能受益最大的人受益。一个强大的统计和数据 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 和青壮年艾滋病毒的预防和护理。为了为这个ATN融资周期提供SDMC服务，我们组装了 来自北卡罗来纳大学、埃默斯大学和哈佛大学/麻省总医院的领导团队。这个 SDMC将为所有网络临床研究提供全面的数据管理和分析； 以及监管方面、生物统计、研究设计、分析、解释和结果发布方面的服务。 国家临床医学中心将使用创新的统计方法和最先进的临床试验管理制度， 实验室信息管理系统，确保完整、高质量的数据。国资委领导统一 致力于通过卓越的循证干预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 管理资源，协调和监督ATN及其个人和跨网络 协议，以及更广泛的科学和ATN利益攸关方社区。国家计委负责 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密性和重复性 这项申请中提出的研究和未来在ATN项目周期中新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指南。此外，国资委将 领导工作，使ATN内的数据管理和统计活动标准化和协调一致 以及其他由NIH赞助的项目。在个人研究的整个生命周期内，国家药品监督管理委员会将协调 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的总体研究议程。在这些活动中，国资委将刻意 通过指导和参与，促进更公平地使用、获取和传播数据 受训人员、早期调查人员和在SDMC活动中代表不足的少数群体。我们已经组建了一支 多元化团队，在统计分析、流行病学方面拥有互补的领导经验和专业知识 艾滋病毒、统计建模和成本分析、青少年和青壮年艾滋病毒干预发展和 评估、循证临床护理、网络科学和多站点、多研究生物医学和行为学 临床试验。我们的SDMC领导模式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。