The aim of this proposal is to enable Dr. Ojo to devote 50% effort to conduct clinical research and to mentor patient-oriented research trainees. The research projects that will be principally utilized for the proposed mentoring plan are: (1) The Chronic Renal Insufficiency Cohort Study (CRIC); (2) The Folic Acid for Vascular Outcome Reduction in Transplantation Study (FAVORIT); and (3) The Scientific Registry for Transplant Recipients (SRTR). CRIC is an NIH-sponsored, multicenter, prospective cohort study designed to determine the risk factors for accelerated decline in renal function and to evaluate the incidence and risk factors for cardiovascular disease (CVD) in patients with chronic renal insufficiency (CRI). The CRIC will provide the mentored trainees with hands-on application of a nonexperimental study design. The FAVORIT is an NIH-sponsored, multicenter, randomized, double-blind controlled clinical trial designed to determine whether total homocysteine (tHcy)-lowering treatment with a standard multivitamin augmented by a high dose combination of folic acid, vitamin B 12, and vitamin B6 versus treatment with a standard multivitamin devoid of these three B-vitamins, reduces the pooled rate of recurrent and de novo CVD outcomes in stable renal transplant recipients. The FAVORIT will be used as a template to instruct the trainees in the design, conduct and analysis of randomized clinical trials. The SRTR is a longitudinal database designed to conduct scientific investigations of patient-centered outcomes relevant to solid organ retrieval, allocation, and transplantation in the U.S. The SRTR will serve the trainee as a practicum for hypothesis-driven clinical epidemiologic outcome studies. Mentoring Plan: This award will entail the development and implementation of an integrated mentoring program starting from the first year of fellowship and consisting of three key components: (1) the practical experience of an observational study of 500 patients (CRIC), a randomized therapeutic clinical trial of 200 patients (FAVORIT) and outcomes analyses with a database of 300,000 organ recipients (SRTR); (2) rigorous didactic instructions in patient-oriented research methodologies through a Master degree in Clinical Research or Epidemiology program or flexibly designed set of course work; and (3) continuous training on rights, ethics and responsibilities in research with human subjects through the University of Michigan Research Responsibility Program.
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