Coordinating Center for the Drug Induced Liver Injury Network (DILIN)

描述（由申请人提供）：国家糖尿病、消化和肾脏疾病研究所（NIDDK）提议继续进行药物性肝损伤网络（DILIN）。如RFA所述，DILIN将是一个由多达5个具有DILI诊断和管理专业知识的临床中心（cc）和一个具有管理多中心研究和临床和转化数据集专业知识的数据协调中心（DCC）组成的网络。本研究计划的目的是加强从不同人口和广泛地理分布中登记病例和对照（当合理时）。该网络研究的主要目的是进行药物遗传学分析，以寻找预测性生物标志物和遗传“指纹”，有助于阐明药物性肝损伤（DILI）的发病机制，并最终开发特定的预防和/或治疗方法。杜克临床研究所（DCRI）建议继续作为DILIN的DCC。在这个角色中，我们将运用我们丰富的经验和研究基础设施来协调、支持和促进DILIN网络的活动。特别是，我们将关注以下具体目标：(1)探索并确定在美国广泛的人口和地理分布中使用LiverTox病例报告；(2)支持制定药物遗传学和生物标志物研究方案，以及预防和治疗DILI的干预策略研究；(3)支持开发一种有效的、基于计算机的DILI仪器和诊断，这对临床医生来说是准确、简单和实用的；(4)支持稿件编写；(5)提供整体网络协调和物流；(6)确保质量保证，持续进行数据管理活动；(7)帮助维持LiverTox；(8)在设计和分析问题方面提供统计领导；(9)支持辅助研究。

DESCRIPTION (provided by applicant): The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) have proposed the continuation of the Drug-Induced Liver Injury Network (DILIN). As described in the RFA, DILIN will be a network composed of up to 5 Clinical Centers (CCs) with expertise in diagnosis and management of DILI and a Data Coordinating Center (DCC) with expertise in the management of multicenter studies and clinical and translational datasets. The purpose of this research program is to enhance the enrollment of cases and controls (when justified) from a diverse demographic and wide geographic distribution. The major aim of the network study is to pursue pharmacogenetic analyses to find predictive biomarkers as well as genetic "fingerprints" useful for elucidating the pathogenesis of Drug-Induced Liver Injury (DILI) and ultimately for developing specific means of prevention and or treatment. The Duke Clinical Research Institute (DCRI) proposes to continue as the DCC for DILIN. In this role, we will apply our extensive experience and research infrastructure to coordinate, support and facilitate the activities of the DILIN network. In particular, we will atted to the following specific aims: (1) Explore and Determine the use of LiverTox case report for enrollment from a wide demographic and geographic distribution throughout US; (2) Support protocol development of pharmacogenetic and biomarker studies and studies with intervention strategies to prevent and treat DILI; (3) Support development of a validated, computer-based instrument and diagnosis of DILI which is accurate, simple and practical for clinicians; (4) Support manuscript preparation; (5) Provide overall network Coordination and Logistics; (6) Ensure quality assurance and continue data management activities; (7) Contribute to maintain LiverTox; (8) Provide statistical leadership in design and analysis Issues; (9) Support ancillary studies.