The Clinical Core provides assistance in patient enrollment and follow-up, data management (data collection, computer data entry, and data quality control), datebase and application management, data analysis, and biostatistical support (study design, statistical analyses) for grant investigators, In addition, the Clinical Core will interact with the Administrative Core to ensure seamless provision of data to the Project Pis and to facilitate protection of the safety of research subjects. Each project on the grant requires clinical information. By consolidating clinical transplant data management into a single area (rather than having each Principal Investigator collect his/her required clinical information), quality and accuracy are enhanced. In addition, consolidating data and database application management, is cost effective. For example, clinical outcome is recorded only once, and the database is used for each project. Each investigator can then focus on his/her individual project. The Core will also provide support for data retrieval and biostatistical analysis for all investigators. Again, as clinical data is required for all of the projects, consolidating the statistical support on the Core is cost effective. In addition to the final data analysis, Principal Investigators may obtain advice on the design and interim analyses of studies and surveys. When it is necessary to collect additional data (i.e., beyond what is routinely obtairied and entered), investigators will be advised as to the best methods, so that their data can easily be merged with the data in the database. After analyzing data from a particular study, the biostatistician will also assist the investigator by ensuring that the appropriate statistical analyses are performed and by writing a detailed description of the analyses performed so as to ensure accurate presentation of the data.

Public Health Relevance

The Core will contribute to attainment of each project's objectives in that clinical outcome information (and associated co-morbidities and risk factors) are required for analysis of data for each of the projects. Clinical outcome is an end-point for each of our projects.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Program Projects (P01)
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Special Emphasis Panel (ZDK1-GRB-R)
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University of Minnesota Twin Cities
United States
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Vezina, Heather E; Brundage, Richard C; Balfour Jr, Henry H (2014) Population pharmacokinetics of valganciclovir prophylaxis in paediatric and adult solid organ transplant recipients. Br J Clin Pharmacol 78:343-52
Balfour Jr, Henry H (2014) Editorial commentary: Genetics and infectious mononucleosis. Clin Infect Dis 58:1690-1
Nevins, Thomas E; Robiner, William N; Thomas, William (2014) Predictive patterns of early medication adherence in renal transplantation. Transplantation 98:878-84
Balfour Jr, Henry H (2014) Progress, prospects, and problems in Epstein-Barr virus vaccine development. Curr Opin Virol 6:1-5
Verghese, Priya S; Dunn, Ty B; Chinnakotla, Srinath et al. (2014) Calcineurin inhibitors in HLA-identical living related donor kidney transplantation. Nephrol Dial Transplant 29:209-18
Suszynski, Thomas M; Rizzari, Michael D; Gillingham, Kristen J et al. (2013) Antihypertensive pharmacotherapy and long-term outcomes in pediatric kidney transplantation. Clin Transplant 27:472-80
Najafian, Behzad; Mauer, Michael (2013) Predilection of segmental glomerulosclerosis lesions for the glomerulotubular junction area in type 1 diabetic patients: a novel mapping method. PLoS One 8:e69253
Mauer, Michael; Fioretto, Paola (2013) Pancreas transplantation and reversal of diabetic nephropathy lesions. Med Clin North Am 97:109-14
Ponchiardi, Cecilia; Mauer, Michael; Najafian, Behzad (2013) Temporal profile of diabetic nephropathy pathologic changes. Curr Diab Rep 13:592-9
Suszynski, T M; Gillingham, K J; Rizzari, M D et al. (2013) Prospective randomized trial of maintenance immunosuppression with rapid discontinuation of prednisone in adult kidney transplantation. Am J Transplant 13:961-70

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