Hepatitis B Clinical Research Network - Data Coordinating Center

描述（由申请人提供）：正在建立B型肝炎临床研究网络（HB-CRN），以促进“B型肝炎的研究，重点是阐明发病机制和自然史，并开发治疗和控制手段”。该网络将包括多达10个合作临床中心，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）。该网络将合作建立一个数据库，其中包括临床中心随访的所有B型肝炎患者，特别关注新诊断病例。该网络还将包括一项长期单药与联合治疗慢性B型肝炎的随机对照试验。该网络可能进行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各个方面。DCC将开发分布式数据输入系统，并维护来自临床、病毒学和免疫学中心的临床、实验室和其他相关信息的安全中央数据库。DCC将确定并与其他中央设施（例如，实验室、病理学），并与NIDDK生物样品和遗传学储存库协调。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准备材料。DCC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，以及向数据和安全性监查委员会的报告。最后，我们将分享为HB-CRN收集的数据，参与与更广泛的科学、临床和一般社区的翻译活动，并存档所有数据、研究干预材料，并在研究结束时协调存档所有标本。

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.