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: 7905318
• 负责人: JAMES ROCHON
• 金额: $ 37万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7905318
• 关键词: Address; Ancillary Study; Biometry; Clinical; Clinical Research; Communication; Communities; Data; Data Coordinating Center; Development; Device or Instrument Development; Diagnostic; Enrollment; Ensure; Genetic; Geographic Distribution; Grant; Information Systems; Injury; Internet; Leadership; Link; Liver; Logistics; Mails; Manuals; 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; Sectioning technique; Site; Study Section; System; Training; United States National Library of Medicine; Writing; case control; data management; design; experience; instrument; meetings; metabolomics; organizational structure; outreach; programs; quality assurance; 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）： 美国国家糖尿病与消化和肾脏疾病研究所（NIDDK）提出了药物诱导的肝损伤网络（DILIN）的延续和扩展。如RFA中所述，Dilin将演变为最多8个临床中心（CCS），数据协调中心（DCC）和NIDDK项目办公室的网络。该研究计划的目的是增强来自广泛的人口统计和地理分布的案例和控制的入学，设计可检验的假设，以评估遗传变异性在DILI中的作用，进行药物遗传学分析，并开发基础架构，开发基础架构，以寻找表型基因型的信息，以找到更多的Interal Internity Interlets Interle Impertion和Contection Impartion和Contection and anter Implection和Conterification Implection，并在Conjuntiment上开发了Conjuniperiative，并在Conjuntiment中开发，并在Conjuntiment中发展。药物引起的肝损伤。 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。特别是，我们将关注以下特定目标：（1）培养最初赠款期间开发的有效组织结构； （2）援引质量保证程序，以确保进行这些研究的保真度； （3）将新的临床中心整合到Dilin中； （4）维护在初始赠款期间开发的数据管理系统，以保护累积数据的完整性，准确性和及时性； （5）继续在最初的赠款期内开发报告，以列出进行这些研究的进展； （6）以实质性的方式设计和进行药物遗传学研究； （7）为开发权威DILI网站的NLM计划做出了贡献； （8）有助于开发经过验证的DILI诊断工具； （9）在生物统计学和研究设计方面提供适当有能力的领导和专业知识； （10）支持辅助研究和前瞻性研究。