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

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肝损伤网络(DILIN)。正如RFA中所描述的，DILIN将发展成为一个由多达8个临床中心(CCS)、数据协调中心(DCC)和NIDDK项目办公室组成的网络。这项研究计划的目的是从广泛的人口和地理分布增加病例和对照的登记，设计可测试的假说来评估遗传变异在DILI中的作用，执行药物遗传学分析并开发所需的基础设施来发现表型-基因型关联，向更广泛的科学界传播信息，并与国家医学图书馆合作开发一个权威和完整的药物肝损伤互联网网站。 杜克临床研究所(DCRI)建议继续担任DILIN的DCC。在这一角色中，我们将应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。我们将特别关注以下具体目标：(1)培养在最初的赠款期间发展的有效组织结构；(2)援引质量保证程序，以确保进行这些研究的准确性；(3)将新的临床中心纳入DILIN；(4)维护在最初的赠款期间开发的数据管理系统，以确保积累的数据的完整性、准确性和及时性；(5)继续在最初的赠款期间开发报告，以绘制进行这些研究的进展情况；(6)以实质性的方式为设计和进行药物遗传学研究做出贡献；(7)为国家一级倡议作出贡献，以开发一个权威的帝力机构网站；(8)协助为帝力机构开发经过验证的诊断工具；(9)在生物统计和研究设计方面提供适当和有能力的领导和专门知识；以及(10)支持辅助研究和前瞻性研究。

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.