Biostatistics and Data Management Core

项目摘要(见说明)：将建立生物统计和数据管理核心(F)，以认识到在设计、实施和分析与艾滋病毒/艾滋病精神健康有关的临床和基础研究方面对统计和数据管理专门知识的迫切需要。该中心将为宾夕法尼亚大学精神卫生艾滋病研究中心(PMHARC)的调查人员提供统计合作，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、跨学科和翻译性心理健康。核心将通过跨越核心边界的工作，促进使用严格的统计和分析方法以及有效的数据管理。该中心的具体目标是：就研究设计、数据管理和数据分析问题与PMHARC调查人员合作，包括定性研究和混合模型方法；评估干预研究的可行性并促进先导研究的开展；就每年最多四项先导研究的设计、实施、数据管理和分析进行合作，并开发和维护一个关于所有先导研究中与艾滋病毒、精神疾病和合并症相关的生物标记物的核心评估的纵向评估的中央数据库。一旦参与者参加试点研究，核心数据收集将继续进行，直到P-30的行政管理结束；为研究资金申请提供统计协作(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的方法，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，即税收标准统计方法、推断问题和适当设计的问题。这些负担包括随着时间的推移高度相关的数据以及各种结果衡量标准之间的相关性。因此，该中心的核心F将处理可能不会出现在其他环境中的有趣但复杂的问题(例如，CFAR)。预计随着个人ROI的颁发，Ellenberg博士、Morales博士和Barg博士、生物统计学分析中心(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。总体而言，核心的模式将是利用核心支持的人员努力进行试点项目和编制供资提案，随后获得的赠款直接支持由此产生的合作研究工作。方法工作还将由PMHARC核心资金以及外部授予赠款产生的外部资金提供资金。

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.