Clinical-Component

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PROJECT SUMMARY The overall goal of the Clinical Component of the Digestive Health Center (DHC) is to accelerate the translation of basic research into clinical studies and trials for pediatric digestive diseases. The Clinical Component pursues this goal with three complementary aims. In the first Aim “to provide consultation on study design and biostatistical services for DHC investigators,” the Clinical Component makes available to DHC investigators a web-based portal for services related to study design, statistical analysis, and result reporting. This line of services is led by the Director of the Clinical Component and a biostatistician with expertise on digestive disease studies. Subsidized consultation is also available through the Cincinnati Center for Translational Science and Training and institutional Data Management and Analysis Center (DMAC), which are staffed by statisticians and certified data analysts. In the second Aim “to provide data management and infrastructure for implementation, monitoring, and reporting of patient-based research on digestive diseases,” the Clinical Component makes available to DHC investigators the infrastructure for comprehensive data management services via DMAC, REDcap and other large-data platforms. These platforms count on rigorous security and compliance requirements for clinical and translational research. And in the third Aim “to provide access to tissues and genomic samples for digestive disease research,” the Clinical Component partners with the institutional biobank that is designed to facilitate patient-based research in the pediatric population. The biobank makes it possible for DHC investigators to obtain de-identified stored tissues and relevant disease information for approved studies. It also facilitates the development of customized biorepositories for investigator-initiated projects and helps with submission of IRB proposals focused on studies of digestive diseases. Biostatistical and study design consultations are a key component of the review and ranking of Pilot and Feasibility projects to ensure that applicants use scientifically rigorous approaches when designing pre- clinical and clinical studies. In the current funding period, the Clinical Component supported over 30 DHC Investigators with 12,119 hours of statistical analysis, 10,775 hours of REDCap usage and support, and access to 1,184 tissues from digestive disease organs. We are well positioned to continue to serve the needs of DHC Investigators, integrate our services with other DHC Cores, and accelerate the translation of basic research into clinical studies and trials for pediatric digestive diseases.