Transfusion Medicine/Hemostasis Research Network: DCC

输血医学/止血研究网络：DCC

• 批准号: 6571370
• 负责人: Leslie Kalish
• 金额: $ 95.8万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6571370
• 关键词: adult human (21+); biomedical facility; blood disorder; blood transfusion; children; clinical research; clinical trials; cooperative study; data management; experimental designs; hemostasis; human subject; human therapy evaluation; medical outreach /case finding; patient oriented research; thrombocytopenic purpura; training

DESCRIPTION (provided by applicant): The overall goal of the Transfusion Medicine/Hemostasis Clinical Research Network is to efficiently conduct multi-center clinical studies (primarily randomized clinical trials), to evaluate treatments and management strategies for children and adults with hemostatic disorders. The New England ResearchInstitutes (NERI) proposes to support the Network as Data Coordinating Center (DCC). This proposal describes DCC methods and presents an innovative randomized clinical trial design for the treatment of thrombotic thromocytopenic purpura (TTP). The DCC has the following aims: 1) to collaborate in the selection, design, conduct, analysis and reporting of clinical studies and trials; 2) to establish a mechanism for randomization and monitoring of patient recruitment from both Network and non-Network centers; 3) to develop and maintain a data management system for each Network study; 4) to compile, edit, analyze and report study data; 5) to institute quality control procedures including training study personnel and conducting site visits; 6) to identify central laboratories and repositories, and to develop a system for tracking laboratory specimens and results; 7) to achieve cost and time efficiencies for study start-up by maintaining a standard library of data collection modules; 8) to develop and administer a mechanism for patient recruitment and retention from out-of-network centers; and 9) to coordinate the activities of the Steering Committee, Protocol Review Committee, Data and Safety Monitoring Board with communication and meeting support. The NERI team of investigators offers considerable experience in coordinating complex multi-center studies with expertise in administrative and biostatistical support, data management, quality control procedures and quality of life measurement. Clinical expertise in the fields of hemostasis and transfusion medicine is provided locally by Dr. Kruskall of Beth Israel Deaconess Medical Center. Drs Kalish, Assmann and Kruskall have successful collaborative relationships from prior transfusion-related research projects.

描述（由申请人提供）： 输血医学/止血临床研究网络的总体目标是有效地进行多中心临床研究（主要是随机临床试验），以评估对止血疾病儿童和成人的治疗和管理策略。 新英格兰ResearchInstitutes（NERI）提议支持该网络作为数据协调中心（DCC）。 该建议描述了DCC方法，并提出了一种创新的随机临床试验设计，用于治疗血栓性血栓细胞减少紫红色（TTP）。 DCC具有以下目的：1）在临床研究和试验的选择，设计，进行，分析和报告中进行合作； 2）建立一种从网络和非网络中心对患者招募的随机和监测的机制； 3）为每个网络研究开发和维护一个数据管理系统； 4）编译，编辑，分析和报告研究数据； 5）制定质量控制程序，包括培训研究人员和进行现场访问； 6）识别中央实验室和存储库，并开发一种用于跟踪实验室标本和结果的系统； 7）通过维护标准的数据收集模块库来实现研究初创企业的成本和时间效率； 8）开发和管理一种从网络外中心招募和保留的机制；和9）协调指导委员会，协议审查委员会，数据和安全监控委员会的活动与沟通和会议支持。 NERI调查人员团队在协调复杂的多中心研究方面提供了丰富的经验，并具有行政和生物统计支持，数据管理，质量控制程序和生活质量测量方面的专业知识。 以色列女执事医疗中心的Kruskall博士在本地提供了止血和输血医学领域的临床专业知识。 Kalish博士，Assmann和Kruskall博士与先前与输血相关的研究项目的合作关系成功。