Hepatitis B Clinical Research Network - Data Coordinating Center

描述(由申请者提供)：正在建立乙肝临床研究网络(HB-CRN)，以促进“致力于阐明乙肝的发病机制和自然病史以及开发治疗和控制手段的研究”。该网络将包括最多10个协作临床中心、一个病毒学中心、一个免疫学中心、一个NIDDK项目科学家和一个数据协调中心(DCC)。该网络将合作创建一个所有乙肝患者的数据库，在临床中心跟踪，特别关注新诊断的病例。该网络还将包括长期单一疗法和联合疗法治疗慢性乙肝的随机对照试验。该网络可能会进行2-4项临床试验、临床或流行病学调查。 作为DCC，我们将与HB-CRN成员合作，支持数据库和临床试验的研究设计、研究实施和数据分析的方方面面。疾病预防控制中心将开发一个分布式数据输入系统，并维护一个安全的中央数据库，其中包括临床、病毒学和免疫学中心的临床、实验室和其他相关信息。DCC将根据需要确定其他中央设施(如实验室、病理学)并与之签订合同，并与NIDDK生物样本和遗传学资料库进行协调。DCC将制定安全性和有效性分析计划，并为HB-CRN会议、科学会议以及出版物和监管机构的演示准备材料。协调中心将协调网络的所有活动，包括指导委员会、小组委员会的会议和电话会议，以及向数据和安全监测委员会(S)介绍情况。最后，我们将分享为HB-CRN收集的数据，与更广泛的科学、临床和普通社区参与翻译活动，并在研究结束时存档所有数据、研究干预材料，并协调存档所有标本。

DESCRIPTION (provided by applicant): The Hepatitis B Clinical Research Network (HB-CRN) is being established to promote "research in hepatitis B focusing upon elucidating the pathogenesis and natural history and developing means of treatment and control". The Network will include up to 10 collaborating Clinical Centers, a Virology Center, an Immunology Center, a NIDDK Project Scientist, and a Data Coordinating Center (DCC). This Network will work cooperatively to create a database of all patients with hepatitis B followed at the Clinical Centers with special focus on newly diagnosed cases. The Network will also include a randomized, controlled trial of long-term mono-versus combination therapy for chronic hepatitis B. Possibly 2-4 clinical trials, clinical or epidemiologic investigations will be conducted by the Network. As the DCC, we will work with the HB-CRN members to support all aspects of study design, study conduct, and data analysis for the database and clinical trials. The DCC will develop a distributed data entry system and maintain a secure, central database of clinical, laboratory, and other relevant information from the Clinical, Virology, and Immunology Centers. The DCC will identify and contract with other central facilities (e.g., laboratory, pathology) as needed and coordinate with the NIDDK Biosample and Genetics Repositories. The DCC will develop safety and efficacy analysis plans and prepare materials for presentations at HB-CRN meetings, scientific conferences, and for publications and regulatory bodies. The DCC will coordinate all activities of the Network, including meetings and conference calls for the Steering Committee, subcommittees, and presentations to the Data and Safety Monitoring Board(s). Finally, we will share data collected for the HB-CRN, participate in translation activities with the wider scientific, clinical, and general community and archive all data, study intervention materials, and coordinate archiving all specimens at the end of the study.