Biostatistics Core B will provide collaborative analytic support to all 4 Moffitt Skin SPORE projects, the other 2 Cores, and the Developmental Research and Career Development Programs. Each project has a faculty biostatistician, selected to maximize the link between their applied research focus and the project. There, will be 4 clinical trials, including phase 1 trials in Projects 2 and 3 that will use a modified Ji design, chosen to provide a richer experience in establishing an MTD. This design, which received extensive discussion and included some modification by the Core B statisticians, will receive special ongoing attention as befits a novel analytical approach. Projects 2 and 4 are both very involved from an analytical perspective and will receive the highest proportions of funding. Project 2 involves extensive proteomics analyses and uses a multi-level Bayesian model developed in part by the project 2 statistician. Project 4 is a case-cohort study involving 1500 participants and 3,000 person-years of follow-up, and includes numerous demographic and lifestyle factors to be examined. In conjunction with Cores A and C, this core will play a vital role in SPORE database development, especially with the clinical trials and case-cohort studies. Biostatistics Core B will be involved in the development of all proposed Developmental Research and Career Development Programs, and will provide analytic support to those that are funded. Working under the direction of faculty biostatisticians are two staff statisticians, who will handle a significant share of the direct statistical programming needed.
Biostatistics Core B of the Moffitt Skin SPORE will be responsible for the statistical collaborative SPORE activities related to Projects 1, 2, 3 and 4. Of particular note, the core will provide statistical analytic activities of all four melanoma trials in Projects 1, 2, and 3 and the analytical issues associated with the case-cohort study in Project 4. This core will assist with the development of an analytic plan for all proposed DRP and CDP projects, and will support those that receive funding support.
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