THALASSEMIA CLINICAL RESEARCH NETWORK - DCC

新英格兰研究所 (NERI) 提议充当地中海贫血临床研究网络的数据协调中心，以实现以下目标： 与指导委员会合作选择方案和设计临床试验，特别是提供与设计、实施和分析相关的统计建议；开发和维护网络数据管理系统；开发和维护跟踪所有中心实验室标本的系统；对试验人员进行试验各个方面的培训，进行现场考察，并监控和记录所有收集数据的质量；编译、报告和分析试验数据，并在科学演示和出版物中进行合作；提供行政支持。 NERI 提案的重要特点包括：我们在镰状细胞病多中心研究方面拥有广泛且高度相关的专业知识；涉及镰状细胞性贫血患者输血治疗和丙型肝炎患者干扰素治疗的临床试验；我们在生活质量、医疗保健利用和成本衡量方面的内部专业知识；我们专有的 ADEPT 基于网络的数据管理系统，将数据输入与自动化、集中式随机化、方案和患者跟踪完全集成；我们所有研究方案的模块化方法；最后，我们建议在第 01 年建立资助期间在每个临床中心确定的所有地中海贫血患者的登记册，以便在可行性目标人群和科学方面充分告知所有拟议的临床试验。

New England Research Institutes (NERI) proposes to serve as the Data Coordinating Center for the Thalassemia Clinical Research Network to accomplish the following goals: To collaborate with the Steering Committee in the selection of protocols and the design of the clinical trials, specifically providing statistical advice relevant to design, conduct, and analysis; To develop and maintain a data management system for the Network; To develop and maintain a system for tracking all central laboratory specimens; To train trial personnel in all aspects of the trials, conduct site visits, and monitor and document the quality of all data collected; To compile edit, report on, and analyze trial data and collaborate in scientific presentations and publications; and To provide administrative support. Important features of NERI's proposal include: our extensive, highly relevant expertise in multi-site studies of sickle cell disease; clinical trials involving transfusion therapy of patients with sickle cell anemia and interferon treatment for patients with hepatitis C; our in-house expertise in quality of life, health care utilization and cost measurement; our proprietary ADEPT web-based data management system which fully integrates data entry with automated, centralized randomization and protocol and patient tracking; our modular approach to all study protocols; and finally, our proposal to establish in, Year 01, a registry of all thalassemia patients identified, during the funding period, at each of the clinical centers to fully inform all proposed clinical trials in terms of feasibility target population, and science.