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: 8330958
• 负责人: Huiman X Barnhart
• 金额: $ 144.9万
• 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 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8330958
• 关键词: Address; Ancillary Study; Biometry; Clinical; Clinical Research; Communication; Communities; Data; Data Coordinating Center; Development; Device or Instrument Development; Diabetes Mellitus; Diagnostic; Digestive System Disorders; Enrollment; Ensure; Genetic; Geographic Distribution; Grant; Information Systems; Injury; Institutes; Internet; Kidney Diseases; Leadership; Link; Liver; Logistics; Mails; Manuals; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Pharmaceutical Preparations; Pharmacogenetics; Procedures; Prospective Studies; Proteomics; Protocols documentation; Reporting; Research; Research Design; Research Infrastructure; Research Institute; Research Personnel; Role; Science; Site; System; Techniques; Training; United States National Library of Medicine; Writing; case control; data management; design; experience; instrument; meetings; metabolomics; organizational structure; outreach; programs; quality assurance; symposium; web site; working group

DESCRIPTION (provided by applicant): The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has proposed the continuation and expansion of the Drug-Induced Liver Injury Network (DILIN). As described in the RFA, DILIN will evolve into a network of up to 8 Clinical Centers (CCs), the Data Coordinating Center (DCC), and the NIDDK Project Office. The purpose of this research program is to enhance the enrollment of cases and controls from a wide demographic and geographic distribution, devise testable hypotheses to assess the role of genetic variability in DILI, perform pharmacogenetic analysis and develop the infrastructure needed to find phenotypic-genotypic associations, disseminate the information to the greater scientific community, and develop, in conjunction with the National Library of Medicine, an authoritative and complete internet website for drug-induced liver injury. 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 network. In particular, we will attend to the following specific aims: (1) nurture the efficient organizational structure developed in the initial grant period; (2) invoke quality assurance procedures to ensure fidelity in conducting these studies; (3) integrate the new clinical centers into DILIN; (4) maintain data management systems developed in the initial grant period to safeguard the completeness, accuracy and timeliness of the accumulating data; (5) continue reports developed in the initial grant period to chart progress in conducting these studies; (6) contribute in a substantive manner to design and conduct of pharmacogenetic studies; (7) contribute to the NLM initiative to developed an authoritative DILI website; (8) contribute to the development of a validated, diagnostic instrument for DILI; (9) provide appropriate and capable leadership and expertise in biostatistics and study design; and (10) support ancillary studies and prospective studies.

描述（由申请人提供）： 国家糖尿病、消化和肾脏疾病研究所（NIDDK）建议继续和扩大药物性肝损伤网络（DILIN）。如RFA所述，DILIN将发展成为一个由多达8个临床中心（CC）、数据协调中心（DCC）和NIDDK项目办公室组成的网络。该研究计划的目的是从广泛的人口统计学和地理分布中增加病例和对照的入组，设计可检验的假设以评估遗传变异在DILI中的作用，进行药物遗传学分析并开发发现表型-基因型关联所需的基础设施，将信息传播给更大的科学界，并与国家医学图书馆一起开发，一个权威完整的药物性肝损伤网站。 杜克临床研究所（DCRI）提议继续作为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，支持和促进网络的活动。具体而言，我们将致力于以下具体目标：（1）培养在最初资助期间发展起来的有效组织结构;（2）调用质量保证程序，以确保开展这些研究的忠诚度;（3）将新的临床中心纳入DILIN;（4）维持在资助初期发展的数据管理系统，以确保累积数据的完整性、准确性和及时性;（5）继续编写初始资助期的报告，以记录进行这些研究的进展;（6）以实质性方式为药物遗传学研究的设计和实施做出贡献;（7）为NLM倡议做出贡献，以开发权威的DILI网站;（8）为DILI的有效诊断工具的开发做出贡献;（9）在生物统计学和研究设计方面提供适当和有能力的领导和专业知识;（10）支持辅助研究和前瞻性研究。