Drug Induced Liver Injury Network Data Coordinating Center

摘要 国家糖尿病、消化和肾脏疾病研究所(NIDDK)建议继续 药物性肝损伤网络(DILIN)。如RFA中所述，DILIN将是一个由 最多5个临床中心(CCS)，在诊断和管理DILI方面具有专业知识，并进行数据协调 中心(DCC)，拥有管理多中心研究以及临床和翻译数据集的专业知识。 该网络研究的主要目的是进行遗传分析，以寻找预测性生物标志物以及 基因指纹有助于阐明药物性肝损伤(DILI)的发病机制并最终 用于开发具体的预防和/或治疗手段。杜克临床研究所(DCRI) 建议继续担任DILIN的DCC。在这一职位上，我们将运用我们丰富的经验和研究 协调、支持和便利DILIN网络活动的基础设施。特别是，我们将 注意以下具体目标：(1)支持网络努力提高招聘效率和 效率；(2)支持当前和新的DILIN研究，包括新的机理研究和/或试验；(3) 提供一般DILIN功能的全面网络支持；(4)确保质量保证和数据连续 管理活动；和(5)管理与外部伙伴的分包合同，包括分析核心 国家天然产物研究中心。

ABSTRACT The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has 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 major aim of the network study is to pursue genetic 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 attend to the following specific aims: (1) Support the network’s effort to increase recruitment productivity and efficiency; (2) Support current and new DILIN studies including new mechanistic studies and/or trials; (3) Provide overall network support of general DILIN functions; (4) Ensure quality assurance and continue data management activities; and (5) Administer subcontracts with external partners including the analytical core at the National Center for Natural Products Research.