Saturday, November 23, 2024
11/23/2024
DESCRIPTION (provided by applicant): The Consortium of Food Allergy Research (CoFAR) Statistical and Clinical Coordinating Center (SACCC) will collaborate with the clinical research centers in supporting the development of clinical and mechanistic food allergy research activities. The Consortium will develop new approaches to treat and prevent IgE-mediated food allergy, including food allergy-associated anaphylaxis and food allergy-associated eosinophilic gastrointestinal disease (EGID). The goals will be to: (1) develop immune intervention strategies for prevention and treatment, (2) identify the mechanisms underlying the natural histories of these disorders, and (3) define the genetic components of these disorders. Multi-site, multi-protocol research will be developed and implemented using standardized and documented policies and procedures per U.S. federal regulation, ICH guidelines and Consortium practices to provide the highest level of security and protection to subjects participating in CoFAR observational and treatment studies. Pharmaceutical support will be provided to manufacturer, label, document and distribute investigational study products consistent with industry standards and an independent GMP review will occur prior to study activation. The SACCC will develop and institute training programs for the sites to conduct standardized study assessments that are key to study milestones, particularly with regards to enrollment and endpoint assessments. Data collection and submission standards will be provided using an electronic data management system, data quality tracked, site and safety monitoring reviewed and reported to the Steering Committee, DSMB and FDA. IND submissions will be supported for the duration of the project and the SACCC staff will collaborate with NIAID Office of Regulatory Affairs to support their sponsor files and FDA submission needs. Data will be analyzed for interim reports, abstracts and eventually published in peer reviewed journals and information disseminated to the medical community and public at large. At project completion, data will be provided to the NIH data repository.
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