The Data Management and Analysis Core (Core A) will interact importantly with each of the 4 projects, and the Scientific Core B. We have developed a detailed plan to optimize the synergy and interactions among the projects, cores and personnel involved in the studies proposed in this U19 application by the Stanford Alliance for Food Allergy Research (SAFAR) for a coordinated data analysis strategy. Notably, the members of the SAFAR team are already interacting scientifically. Accordingly, should this application be funded, the proposed work to advance our understanding of the pathology of peanut allergy, and the mechanisms that contribute to tolerance in this disorder, will represent a continuation and substantial expansion of these ongoing collaborative efforts. The Data Management and Analysis Core has three Specific Aims:
Aim 1 : Provide data analysis and statistical support for the phase 2 clinical trial of Project 1, evaluating the primary endpoint of induction of tolerance in peanut allergic patients treated with oral immunotherapy (OIT), and also analyzing ongoing safety data collected in the course of the trial;
Aim 2 : Provide integrated and coordinated statistical analysis of the clinical and immunological assay data that will be collected by Projects 1, 2, 3, 4, and the Scientific Core B, to attempt to identify immune system features that are predictive of whether or not peanut allergic patients will be tolerized by peanut OIT, and to attempt to identify immune system features that can be used to identify patients at increased risk of adverse reactions to OIT;, Aim 3: Provide and maintain a database organizing the data obtained in Projects 1, 2, 3,4 and the Scientific Core B, to facilitate data sharing with other investigators when the initial analysis of the SAFAR project is completed.
This Core will help to ensure that the clinical outcomes of this phase 2 trial of oral immunotherapy for peanut allergy will be analyzed rigorously, and that analysis of the data from the panel of both conventional and novel immunological assays will be coordinated to define cellular mechanisms correlated with the development of tolerance to peanut allergens. This analysis may also highlight immune system features to monitor to optimize the safety and efficacy of oral immunotherapy for this very serious disorder.
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