Hepatitis B Clinical Research Network - Data Coordinating Center

简介（由申请人提供）：现成立乙型肝炎临床研究网络（HB-CRN），以促进“以阐明乙型肝炎发病机制和自然历史为重点的研究，发展治疗和控制手段”。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所有在临床中心随访的乙型肝炎患者的数据库，并特别关注新诊断的病例。该网络还将包括一项慢性乙型肝炎长期单药与联合治疗的随机对照试验。该网络可能将进行2-4项临床试验、临床或流行病学调查。

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.