Food Allergy Research Consortium and Statistical Center

Food Allergy is a public health problem affecting approximately 4% of the United States' population; however, epidemic studies in adults remain scarce. Fortunately, molecular advancements are increasing, leading to a better understanding of the immune mechanisms involved in the pathogenesis of food hypersensitivity. <P> The purpose of this grant application is to fulfill the need of the Food Allergy Research Consortium (FARC) for a Statistical and Clinical Coordinating Center (SACCC). The EMMES Corporation will provide support to selected projects by providing statistical and epidemiological leadership, scientific advice and judgment regarding study design options and protocol development expectations. <P> EMMES staff will implement and manage pre-clinical and clinical trial protocols as well as observational studies conducted by the FARC. EMMES, as the SACCC, proposes to provide operational support by providing project-specific manuals of operating procedures (MOPs) and standard operating procedures (SOPs), assisting project leaders in meeting regulatory requirements (IND filing, safety and adverse event monitoring) and preparation of reports and analyses for presentations and publications. EMMES statisticians will determine appropriate sample sizes to meet study objectives, provide randomization plans for subject allocation and analyze data including potential biomarker data. In addition, as the SACCC, EMMES will provide its established and validated computerized data communication systems to create a web-based data capture, management and information dissemination system to support the project. <P> As part of the data management plan, EMMES will assume responsibility for tracking all biologic specimens. Finally, as the SACCC, EMMES will provide statistical, technical and logistical support to the committees on which it serves (Steering Committee (SC) and Data Safety Monitoring Board (DSMB). EMMES has provided similar support for collaborative efforts for over 25 years and our proposed staff has specific expertise to support the studies envisioned for the FARC.