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

摘要 处方药和非处方药或草药和膳食补充剂(HDS)引起的肝损伤是一种 美国重要的医疗、科学和公共卫生问题。药物性肝损伤(DILI) 食品和药物管理局不批准、撤回、限制使用和临床监测的最常见原因 药品监督管理局(FDA)。国家糖尿病肾脏病研究所(NIDDK) 卫生研究所于2003年成立了药物性肝损伤网络，并提出了 狄林的延续。正如RFA中所描述的，DILIN将是一个由六个临床中心组成的网络 (CCS)识别和登记符合DILIN资格的患者，以及一个数据协调中心(DCC)提供 DILIN的管理、后勤和分析职能。网络研究的未来领域是继续 DILI的临床、生化、组织学和生物学特征，为今后的研究奠定基础 治疗严重的帝力，并利用有关帝力的信息进行药物警戒。杜克大学的临床研究 研究所(DCRI)建议继续担任DILIN的DCC。在这个角色中，我们将运用我们广泛的 经验和研究基础设施，以协调、支持和促进DILIN网络的活动。 我们将特别关注以下具体目标：(1)支持分析核心的化学分析 草药和膳食补充剂；(2)为识别遗传和非遗传生物标记物提供统计领导 为帝力设计治疗试验，改善帝力的自然历史；(3)支持稿件准备 和辅助研究；(4)提供整体网络协调和后勤；(5)确保质量保证和 继续数据管理活动；(6)为维护liverTox做出贡献。

Abstract Liver injury due to prescription drug and non-prescription drugs or Herbal and Dietary supplement (HDS) is an important medical, scientific, and public health problem in the United States. Drug-induced liver injury (DILI) is the most common reason for non-approval, withdrawal, limitation in use, and clinical monitoring by the Food and Drug Administration (FDA). The National Institute of Diabetes and Kidney Diseases (NIDDK) of the National Institute of Health established the Drug Induced liver injury Network (DILIN) in 2003 and has proposed the continuation of the DILIN. As described in the RFA, the DILIN will be a network composed of six Clinical Centers (CCs) to identify and enroll patients eligible for DILIN and one Data Coordinating Center (DCC) to provide managerial, logistic, and analytic functions for the DILIN. The future areas of the network study is to continue the clinical, biochemical, histologic and biologic characterization of DILI, to lay groundwork for future studies of treating severe DILI and to engage pharmacovigilance with information on DILI. The Duke Clinical Research Institute (DCRI) proposes to continue as the DCC for the 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 analytic core with chemical analyses of herbal and dietary supplements; (2) Provide statistical leadership to identify genetic and non-genetic biomarkers for DILI and to design treatment trial to improve the natural history of DILI; (3) Support manuscript preparation and ancillary studies; (4) Provide overall network coordination and logistics; (5) Ensure quality assurance and continue data management activities; (6) Contribute to maintain LiverTox.