Transfusion Medicine/Hemostasis Research Network: DCC

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），以评估患有止血疾病的儿童和成人的治疗和管理策略。 新英格兰研究所（NERI）建议支持网络作为数据协调中心（DCC）。 该提案描述了DCC方法，并提出了一种治疗血栓性血小板减少性紫癜（TTP）的创新随机临床试验设计。 DCC有以下目标：1）在临床研究和试验的选择、设计、实施、分析和报告方面进行合作; 2）建立一种机制，用于从网络中心和非网络中心招募患者的随机化和监测; 3）为每项网络研究开发和维护一个数据管理系统; 4）汇编、编辑、分析和报告研究数据; 5）建立质量控制程序，包括培训研究人员和进行现场访问; 6）确定中心实验室和储存库，并开发跟踪实验室标本和结果的系统; 7）通过维护数据收集模块的标准图书馆，实现研究启动的成本和时间效率; 8）制定和管理从网络外中心招募和保留患者的机制;和9）协调指导委员会、方案审查委员会、数据和安全性监测委员会的活动，并提供沟通和会议支持。 NERI的研究者团队在协调复杂的多中心研究方面拥有丰富的经验，并拥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。 Beth Israel Deaconess Medical Center的Kruskall博士在当地提供止血和输血医学领域的临床专业知识。 Drs Kalish，Assmann和Kruskall在之前的输血相关研究项目中有着成功的合作关系。

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.