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。《临床》 Component追求这个目标有三个相辅相成的目标。《在第一个目的》提供学习咨询 为DHC研究人员提供的设计和生物统计服务：临床部分提供给DHC 研究人员提供与研究设计、统计分析和结果报告相关的服务的网络门户。 这一系列服务由临床部分主任和一名具有以下专长的生物统计学家领导 消化系统疾病研究。补贴会诊也可以通过辛辛那提中心获得 翻译科学和培训以及机构数据管理和分析中心(DMAC)，它们是 由统计学家和认证数据分析师组成。在第二个目标中“提供数据管理和 实施、监测和报告以患者为基础的消化系统疾病研究的基础设施， 临床组件为DHC研究人员提供了全面数据的基础架构 通过DMAC、RedCap等大数据平台提供管理服务。这些平台依赖于严格的 临床和转化性研究的安全性和合规性要求。在第三个目标中，“提供 获取组织和基因组样本以进行消化系统疾病研究“，临床部分与 机构生物库，旨在促进儿科人群中以患者为基础的研究。这个 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 已批准研究的信息。它还促进了定制生物资源库的开发 研究人员发起的项目，并帮助提交以消化研究为重点的IRB建议 疾病。生物统计学和研究设计咨询是试点审查和排名的关键组成部分 和可行性项目，以确保申请者在设计预案时使用科学严谨的方法 临床和临床研究。在本供资期间，临床部分支助了30多个DHC 调查人员拥有12,119小时的统计分析，10,775小时的RedCap使用和支持，以及 获取来自消化疾病器官的1,184个组织。我们处于有利地位，能够继续满足客户的需求 DHC调查人员，将我们的服务与其他DHC核心集成在一起，并加快BASIC 儿科消化系统疾病的临床研究和试验研究。

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 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.