Clinical-Component

项目摘要 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 组件通过三个互补的目标来实现这一目标。在第一个目标中，“为研究提供咨询 为DHC研究者提供设计和生物统计服务，”临床部分为DHC提供 研究者可以使用基于网络的门户网站，提供与研究设计、统计分析和结果报告相关的服务。 该服务线由临床部分总监和一名生物统计学家领导，该生物统计学家具有以下专业知识： 消化系统疾病研究。也可以通过辛辛那提中心获得补贴咨询， 转化科学和培训以及机构数据管理和分析中心（DMAC）， 工作人员为统计学家和经认证的数据分析师。第二个目标是“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，” 临床部分为DHC调查人员提供了获取综合数据的基础设施 通过DMAC、REDcap等大数据平台提供管理服务。这些平台依靠严格的 临床和转化研究的安全和合规性要求。在第三个目标中，“提供 获得消化系统疾病研究的组织和基因组样本，”临床组件与 机构生物库，旨在促进儿科人群中基于患者的研究。的 生物库使DHC研究人员能够获得去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储存库的开发， 制药商发起的项目，并帮助提交IRB的建议，重点是消化系统的研究 疾病生物统计学和研究设计咨询是试点项目审查和排名的关键组成部分 和可行性项目，以确保申请人在设计预 临床和临床研究。在本供资期内，临床部分支持了30多个地区保健中心， 研究人员进行了12，119小时的统计分析，10，775小时的REDCap使用和支持，以及 从消化系统疾病器官获取1,184个组织。我们有能力继续满足 DHC调查员，将我们的服务与其他DHC核心整合，并加快基本的 研究儿科消化系统疾病的临床研究和试验。

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.