THALASSEMIA CLINICAL RESEARCH NETWORK - DCC

地中海贫血临床研究网络 - DCC

• 批准号: 6760189
• 负责人: ELIZABETH C WRIGHT
• 金额: $ 68.82万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6760189
• 关键词: biomedical registry /referral center; clinical research; cooperative study; data management; human data; patient /disease registry; thalassemia; tissue resource /registry

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.

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，具体提供与设计、进行和分析有关的统计建议；为网络开发和维护数据管理系统；开发和维护跟踪所有中心实验室标本的系统；培训试验人员各方面，进行现场访问，监测和记录收集的所有数据的质量；编辑、报告和分析试验数据，并在科学报告和出版物中合作；并提供行政支持。NERI建议的重要特征包括：我们在镰状细胞疾病多点研究中广泛的、高度相关的专业知识；涉及镰状细胞贫血患者的输血治疗和丙型肝炎患者的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；我们专有的熟练的基于网络的数据管理系统，它完全集成了数据输入与自动化、集中式随机化、方案和患者跟踪；我们对所有研究方案的模块化方法；最后，我们建议在01年建立所有地中海贫血患者的登记，在筹资期间，在每个临床中心确定，以充分告知所有拟议的临床试验在可行性、目标人群和科学方面的情况。