The Biostatistics and Data Management Core (Core F) was 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 provides the Penn Mental Health AIDS Research Center (PMHARC) pilot investigators with collaboration for planning and execution of exploratory investigations, proposal development, and guidance on quantitative and qualitative data management and analyses. The overall mission of Core F is to encourage and facilitate high quality innovative, interdisciplinary and translational mental health in HIV/AIDS research in the PMHARC. The Core promotes 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: 1) advise and collaborate with PMHARC investigators on study design, data management, and data analysis, including qualitative research and mixed methods approaches; 2) evaluate feasibility of intervention studies and facilitate conduct of precursor pilot studies; 3) collaborate on the design, implementation, data management and analysis for four to six pilot studies per year; 4) maintain and expand the central database of the PMHARC's core set of clinical assessments and biomarkers related to HIV, mental illness, and co-morbidities collected from pilot studies and facilitate future research involving the use of the PMHARC pooled database; and 5): provide statistical collaboration for research funding applications (e.g. R01, R21, R34). Many projects 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 nonadherence to treatment, missing data, correlated data over time, and correlation among various outcome measures. Thus Core F is equipped to deal with interesting but complex issues that might not present themselves in other environments (e.g. CFAR). It is expected that as individual R01s are awarded that faculty, the Biostatistics Analysis Center (BAC), and the Mixed Methods Research Lab (MMRL) 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 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.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Center Core Grants (P30)
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Special Emphasis Panel (ZMH1)
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University of Pennsylvania
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