Biostatistics and Data Management Core

生物统计和数据管理核心

• 批准号: 8866241
• 负责人: JONAS H ELLENBERG
• 金额: $ 20.96万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8866241
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Area; Award; Basic Science; Biological Markers; Biometry; Client; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Comorbidity; Complement; Complex; Computer software; Consult; Data; Data Analyses; Data Collection; Data Set; Databases; Development; Diagnostic; Enrollment; Environment; Epidemiologic Studies; Epidemiology; Faculty; Floor; Funding; Genomics; Grant; Graph; HIV; Health Services Research; Health system; Human Resources; Individual; Informatics; Information Systems; Instruction; Intervention Studies; Investigation; Leadership; Mental Health; Mental disorders; Methodology; Methods; Mission; Modeling; Morale; Online Systems; Outcome Measure; Participant; Pennsylvania; Physical environment; Pilot Projects; Preparation; Publications; Qualitative Research; Research; Research Design; Research Methodology; Research Personnel; Research Project Grants; Resources; Services; Staging; Statistical Methods; Taxes; Time; Training; Universities; Work; data management; design; health data; innovation; interest; longitudinal database; member; operation; programs; square foot; systems research; technical report; user-friendly

PROJECT SUMMARY (See instructions): The Biostatistics and Data Management Core (F) will be established in recognition of the critical need for statistical and data management expertise in the design, implementation, and analysis of clinical and basic research related to mental health in HIV/AIDS. The Core will provide Penn Mental Health AIDS Research Center (PMHARC) investigators with statistical collaboration for planning of exploratory investigations and proposal development, and data management and informatics expertise for research planning. The overall mission of Core F will be to encourage and facilitate high quality innovative, interdisciplinary and translational mental health in HIV/AIDS research in the PMHARC. The Core will promote the use of rigorous statistical and analytic methodologies and effective data management by working across the Core boundaries. The Core's specific aims will be to: Advise and collaborate with PMHARC investigators on study design, data management, and data analysis issues, including qualitative research and mixed model approaches; Evaluate feasibility of intervention studies and facilitate conduct of precursor pilot studies; Collaborate on the design, implementation, data management and analysis for up to four pilot studies per year, and develop and maintain a central database of longitudinal assessments on a core set of assessments of biomarkers related to HIV, mental illness, and co-morbidities across all pilot studies. Once a participant is enrolled into a pilot study, the core data collection will continue on that participant until the administrative end of the P-30; Provide statistical collaboration for research funding applications (e.g. ROI, R21, R34); Adapt or develop new statistical methods. Many projects on which Core statisticians provide collaboration can be completed with the use of standard statistical methods, but in some cases it is necessary to either adapt existing methods or develop new ones in order to achieve a satisfactory analysis. Mental health data carries with it substantial structural burdens that tax standard statistical methodology, issues of inference, and issues of appropriate design. These burdens include highly correlated data over time and correlation among various outcome measures. Thus Core F for this Center will be dealing with interesting but complex issues that might not present themselves in other environments (e.g. CFAR). It is expected that as individual ROIs are awarded, that Drs. Ellenberg, Morales, and Barg, the Biostatistics Analysis Center (BAC) and the Clinical Computing and Research Unit (CRCU) will be part of the research team as appropriate to size and complexity of study. In general, the Core's model will be to utilize personnel effort that is supported by the Core for pilot projects and preparation of funding proposals, with the subsequent funded grants providing direct support of the resulting collaborative research effort. Methodological work will also be financed by PMHARC core funding as well as from outside funding generated from external awarded grants.

项目摘要（见说明）：认识到在设计、实施和分析与艾滋病毒/艾滋病心理健康有关的临床和基础研究方面迫切需要统计和数据管理专门知识，将设立生物统计和数据管理核心(F)。该中心将为宾夕法尼亚大学精神健康艾滋病研究中心（PMHARC）的研究人员提供统计合作，以规划探索性调查和提案开发，并为研究规划提供数据管理和信息学专业知识。核心F的总体任务将是鼓励和促进PMHARC在艾滋病毒/艾滋病研究方面的高质量创新、跨学科和转化性精神卫生。核心将通过跨核心边界开展工作，促进使用严格的统计和分析方法以及有效的数据管理。核心的具体目标将是：就研究设计、数据管理和数据分析问题，包括定性研究和混合模型方法，向PMHARC研究人员提供建议和合作；评估干预研究的可行性，并促进前体试点研究的进行；在每年最多四项试点研究的设计、实施、数据管理和分析方面开展合作，并在所有试点研究中开发和维护一套与艾滋病毒、精神疾病和合并症相关的生物标志物核心评估的纵向评估中央数据库。一旦参与者被纳入试点研究，该参与者的核心数据收集将继续进行，直到P-30行政结束；为研究经费申请提供统计合作（如ROI， R21, R34）；适应或发展新的统计方法。核心统计学家提供合作的许多项目可以使用标准统计方法完成，但在某些情况下，有必要调整现有方法或开发新方法，以实现令人满意的分析。心理健康数据带来了巨大的结构性负担，对标准统计方法、推理问题和适当设计问题造成了负担。这些负担包括随时间高度相关的数据和各种结果测量之间的相关性。因此，该中心的Core F将处理在其他环境（例如CFAR）中可能不会出现的有趣但复杂的问题。预计，随着个人投资回报率的授予，博士。Ellenberg， Morales和Barg，生物统计分析中心（BAC）和临床计算和研究单位（CRCU）将根据研究的规模和复杂性成为研究小组的一部分。一般来说，核心的模式将是利用由核心支持的人员努力进行试点项目和准备资助提案，随后的资助赠款为最终的合作研究工作提供直接支持。方法工作也将由PMHARC的核心资金以及由外部授予的赠款产生的外部资金资助。