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

药物性肝损伤网络协调中心 (DILIN)

• 批准号: 9985510
• 负责人: Huiman X Barnhart
• 金额: $ 61.73万
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9985510
• 关键词: Acute; Adverse event; Ancillary Study; Area; Big Data Methods; Biochemical; Biological; Chemicals; Clinical; Clinical Investigator; Clinical Research; Communication Tools; Coupled; Data; Data Analyses; Data Coordinating Center; Databases; Development; Diabetes Mellitus; Diagnosis; Drug Prescriptions; Electronic Mail; Enrollment; Ensure; Future; Genetic; Genetic Determinism; Grant; Herbal supplement; Histologic; Incidence; Institutes; Internet; Kidney Diseases; Knowledge; Lead; Leadership; Liver diseases; Logistics; Manuals; Manuscripts; Medical; Medical Genetics; Methodology; Natural History; Non-Prescription Drugs; Pathway interactions; Patients; Periodicity; Pharmaceutical Preparations; Preparation; Procedures; Process; Public Health; Reaction; Reporting; Research Infrastructure; Research Institute; Role; Statistical Data Interpretation; Statistical Methods; System; Time; United States; United States Food and Drug Administration; United States National Institutes of Health; Withdrawal; Work; Writing; biomarker discovery; data management; design; experience; food surveillance; high risk; improved; liver injury; meetings; non-genetic; novel; operation; patient population; pharmacovigilance; quality assurance; response; symposium; therapy design; treatment trial; web site

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.

摘要 由于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 这是美国重要的医学、科学和公共卫生问题。药物性肝损伤（DILI） 食品和药物管理局未批准、撤回、限制使用和临床监测的最常见原因， 药品管理局（FDA）。国家糖尿病和肾脏疾病研究所（NIDDK） 美国卫生研究所于2003年建立了药物性肝损伤网络（DILIN），并提出了 迪林的延续。如RFA所述，DILIN将是一个由六个临床中心组成的网络 (CCs)确定并招募符合DILIN标准的患者，并由一个数据协调中心（DCC）提供 DILIN的管理、后勤和分析职能。未来的网络研究领域是继续 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。 治疗重度DILI，并利用DILI信息进行药物警戒。杜克临床研究 研究所（DCRI）提议继续担任DILIN的DCC。在这一角色中，我们将广泛运用 经验和研究基础设施，以协调，支持和促进DILIN网络的活动。 特别是，我们将致力于以下具体目标：（1）支持分析核心的化学分析， 草药和膳食补充剂;（2）提供统计领导，以确定遗传和非遗传生物标志物 为DILI和设计治疗试验，以改善DILI的自然史;（3）支持手稿准备 （4）提供整体网络协调和后勤服务;（5）确保质量保证， 继续数据管理活动;（6）维护LiverTox。