Biostatistics and Data Management Core

生物统计和数据管理核心

• 批准号: 8670027
• 负责人: JONAS H ELLENBERG
• 金额: $ 21.35万
• 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
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8670027
• 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; 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）：生物统计和数据管理核心（F）将建立在认识到统计和数据管理专业知识的设计，实施和分析的临床和基础研究有关的艾滋病毒/艾滋病的心理健康的关键需求。该核心将为宾夕法尼亚州心理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制定，以及数据管理和信息学专业知识，用于研究规划。核心F的总体使命将是鼓励和促进PMHARC在艾滋病毒/艾滋病研究中的高质量创新，跨学科和转化精神卫生。核心将通过跨核心界限开展工作，促进使用严格的统计和分析方法以及有效的数据管理。该核心的具体目标是：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研究人员提供咨询和合作;评估干预研究的可行性，并促进前体试点研究的开展;就每年最多四项试点研究的设计、实施、数据管理和分析进行合作，开发和维护一个纵向评估的中央数据库，该数据库涉及所有试点研究中与艾滋病毒、精神疾病和合并症相关的生物标志物的核心评估集。一旦参与者入组试点研究，将继续收集该参与者的核心数据，直到P-30的行政结束;为研究资金申请提供统计合作（例如ROI，R21，R34）;调整或开发新的统计方法。核心统计人员提供协作的许多项目可以通过使用标准统计方法来完成，但在某些情况下，必须调整现有方法或开发新方法，以实现令人满意的分析。心理健康数据承载着大量的结构性负担，这些负担包括标准统计方法、推断问题和适当设计问题。这些负担包括随着时间的推移高度相关的数据和各种结果指标之间的相关性。因此，该中心的核心F将处理在其他环境中可能不会出现的有趣但复杂的问题（例如CFAR）。预计随着个人ROI的授予，Ellenberg、Morales和Barg博士、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团队的一部分。一般而言，核心方案的模式将是利用核心方案支助的人员努力开展试验项目和编制供资提案，随后的资助赠款将直接支助由此产生的合作研究工作。方法学工作还将由PMHARC核心资金以及外部赠款产生的外部资金提供资金。