Coordinating Center for Hepatotoxicity Network

肝毒性网络协调中心

• 批准号: 6682250
• 负责人: JAMES ROCHON
• 金额: $ 69.3万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6682250
• 关键词: biomedical facility; clinical research; cooperative study; data management; hepatotoxin; human subject; liver disorder; sample collection; statistics /biometry

DESCRIPTION (provided by applicant): The NIDDK has proposed a research program to establish and maintain the infrastructure for a Hepatotoxicity Clinical Research Network (HCRN). This network will comprise 4-5 Clinical Centers (CCs) and a Data Coordinating Center (DCC). The primary objective of the HCRN is to develop standardized instruments to identify and fully characterize bona fide cases of drug-, CAM- and toxin-induced liver injury. This will allow for an investigation of the full epidemiological and clinical spectrum of hepatotoxicity. Biological samples will be obtained for the study of the pathogenesis of hepatotoxicity using biochemical, serological and genetic techniques. This initiative will expand current understanding of the mechanisms of drug and toxin-induced liver injury and provide the basis for more effective and safer medical therapies. The Duke Clinical Research Institute (DCRI) proposes to serve as the Data Coordinating Center for this project. In this role, we will apply our considerable experience and resources to coordinate and facilitate the activities of this study and to ensure that scientifically defensible conclusions can be drawn. In particular, we will attend to the following functions: (1) Study Coordination: an efficient organizational structure will be established to ensure that activities advance in a coordinated fashion. (2) Site Management and Monitoring: we will develop a site management plan to safeguard the integrity of the accumulating data. (3) Data Management Activities: we will apply a comprehensive system for on-going data collection and generate reports summarizing progress in the conducting the study. (4) Statistical Analysis: we will provide statistical leadership in the design of these studies, and perform statistical analyses in an expeditious and timely manner.

描述（由申请人提供）： NIDDK提出了一项研究计划，以建立和维护肝毒性临床研究网络（HCRN）的基础设施。该网络将包括4-5个临床中心（CCS）和数据协调中心（DCC）。 HCRN的主要目的是开发标准化仪器，以识别并充分表征药物，CAM和毒素诱导的肝损伤的真正病例。这将允许研究肝毒性的全部流行病学和临床光谱。将获得生物样品，以研究使用生化，血清学和遗传技术的肝毒性发病机理。该倡议将扩大对药物和毒素诱导的肝损伤机制的当前理解，并为更有效，更安全的医疗疗法提供基础。 杜克临床研究所（DCRI）建议作为该项目的数据协调中心。在此角色中，我们将运用我们的丰富经验和资源来协调和促进本研究的活动，并确保可以得出科学辩护的结论。特别是，我们将关注以下功能：（1）研究协调：将建立有效的组织结构，以确保活动以协调的方式进行。 （2）站点管理和监视：我们将制定一个站点管理计划，以保护累积数据的完整性。 （3）数据管理活动：我们将应用一个综合系统，用于正在进行的数据收集并生成总结研究进展的报告。 （4）统计分析：我们将在这些研究的设计中提供统计领导，并迅速及时进行统计分析。