Clinical Component

项目总结 消化健康中心(DHC)临床部分的总体目标是加速 将基础研究转化为儿科消化系统疾病的临床研究和试验。该组件 追求这一目标有三个相辅相成的目标。在第一个目标中“提供研究设计和研究的咨询 为DHC研究人员提供的生物统计服务，临床部分为DHC研究人员提供了 基于Web的门户网站，提供与研究设计、统计分析和结果报告相关的服务。这一行 服务由临床部分主任和一名在消化方面有专长的生物统计学家领导 疾病研究。补贴咨询通过辛辛那提翻译中心提供 科学和培训和机构生物统计研究股，其工作人员为统计学家和数据 分析家。第二个目标是“为执行和监测提供数据管理和基础设施 在基于患者的研究中，该组件为DHC调查人员提供了 与红帽等大数据平台提供全面的数据管理服务。这些平台 临床和转化性研究需要严格的安全性和合规性要求。而在第三个 目的“为消化系统疾病研究提供组织和基因组样本” 与机构生物库合作，旨在促进儿科以患者为基础的研究 人口。生物库使DHC调查人员有可能获得未识别的储存组织和 相关疾病信息，用于经批准的研究。它还促进了定制的 研究人员发起的项目的生物信息库，并帮助提交IRB建议，重点是 消化系统疾病的研究。

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 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 made available through the Cincinnati Center for Translational Science and Training and institutional Biostastistical Research Unit, which is staffed by statisticians and data analysts. In the second aim “to provide data management and infrastructure for implementation and monitoring of patient based research, the Component makes available to DHC investigators the infrastructure for comprehensive data management services with 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 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.