Transfusion Medicine/Hemostasis Research Network: DCC

输血医学/止血研究网络：DCC

基本信息

批准号：
7122530
负责人：
SUSAN FERA ASSMANN
金额：
$ 110.34万
依托单位：
NEW ENGLAND RESEARCH INSTITUTES, INC.
依托单位国家：
美国
项目类别：
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/7122530
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

项目摘要

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开展多中心临床研究（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) 建议支持该网络作为数据协调中心 (DCC)。该提案描述了 DCC 方法，并提出了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 的目标如下： 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) 建立网络中心和非网络中心患者招募的随机化和监测机制； 3）为每个网络研究开发和维护数据管理系统； 4）整理、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考察； 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库来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； 9) 协调指导委员会、方案审查委员会、数据和安全监测委员会的活动，并提供沟通和会议支持。 NERI 的研究团队在协调复杂的多中心研究方面拥有丰富的经验，在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拥有专业知识。贝斯以色列女执事医疗中心的 Kruskall 博士在当地提供止血和输血医学领域的临床专业知识。 Kalish、Assmann 和 Kruskall 博士在之前的输血相关研究项目中建立了成功的合作关系。