Phase I/II Trials of Silymarin for Chronic Liver Diseases Data Coordinating Cente

描述(由申请人提供)：一个包括4个临床站点、一个数据协调中心、以及来自国家补充和替代医学中心(NCCAM)和国家糖尿病、消化与肾脏疾病研究所(NIDDK)的项目科学家和医务人员组成的财团正在形成合作协议，以设计和实施水飞蓟素在肝病患者中的L/11期三期试验。尽管水飞蓟素用于治疗肝病已有数百年的历史，但还没有严格的研究表明这种疗法是安全或有效的。水飞蓟素有潜在的作用，特别是对于那些有干扰素和利巴韦林治疗禁忌症的慢性丙型肝炎患者。目前缺乏对非酒精性脂肪性肝炎的治疗，为水飞蓟素在治疗这种情况下的患者提供了潜在的作用。 我们建议的DCC将汇集生物统计学、药效学和药动学，特别是水飞蓟素、肝病学、流行病学、数据管理和计算机系统方面的专业知识，以帮助该财团设计和实施多项研究。DCC将与临床站点和NIH科学家和人员合作，在以下方面向该财团提供援助： 1.近三个多中心L/11期临床试验的研究设计、实施和管理。 2.开发研究数据库，其中包含在4个临床地点招募的大约480名参与者的信息，以研究水飞蓟素治疗肝病患者的安全性和有效性。 3.提供临床、方法学、数据管理和统计方面的专业知识，以设计研究、准确地将数据计算机化、监控研究操作和患者安全、分析数据并报告结果。 4.向指导委员会、指导委员会各小组委员会、国家卫生研究院项目科学家和医务人员以及数据和安全监测委员会提供行政支助。

DESCRIPTION (provided by applicant): A consortium including 4 clinical sites, a data coordinating center, and project scientists and medical officers from the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is being formed as a cooperative agreement to design and implement three phase l/ll trials of silymarin for patients with liver disease. Although silymarin has been used to treat liver disease for hundreds of years, there has not been rigorous research to indicate that such therapy is safe or efficacious. There is a potential role for silymarin, particularly for treating patients with chronic hepatitis C virus who have contraindications to therapy with interferon and ribavirin. The current lack of therapy for non-alcoholic steatohepatitis provides silymarin with a potential role in treating patients with this condition. Our proposed DCC will bring together expertise in biostatistics; pharmacodynamics and pharmacokinetics, particularly of silymarin; hepatology; epidemiology; data management; and computer systems to assist the consortium with designing and implementing multiple studies. Working in collaboration with the clinical sites and NIH scientists and personnel, the DCC will provide the consortium with assistance in: 1. Study design, implementation, and management of approximately three multi-center phase l/ll clinical trials. 2. Developing research databases containing information about approximately 480 participants recruited at 4 clinical sites to address safety and efficacy of silymarin for treating patients with liver disease. 3. Provide clinical, methodological, data management, and statistical expertise to design the studies, accurately computerize the data, monitor study operations and patient safety, analyze the data, and report the results. 4. Provide administrative support to the Steering Committee, subcommittees of the Steering Committee, NIH project scientists and medical officers, and Data and Safety Monitoring Board.