Transfusion Medicine/Hemostasis Clinical Trials Network-Data Coordinating Center

输血医学/止血临床试验网络-数据协调中心

基本信息

批准号：
7500797
负责人：
SUSAN FERA ASSMANN
金额：
$ 575.95万
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 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7500797
关键词：
Adult Adverse event Area Blood Blood Clot Blood Platelets Blood coagulation Blood specimen Caring Child Clinical Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Network Clinical Trials, Other Commit Communication Communities Companions Conduct Clinical Trials Contracts Critiques Data Data Coordinating Center Data Quality Data Reporting Data Set Development Disease Dose Eligibility Determination End Point Enrollment Funding Future Goals Healthcare Hematological Disease Hematology Hemorrhage Hemostatic Agents Hemostatic function Human Resources Image Image Analysis Institutes Laboratories Medical Medicine Methods Monitor Multi-Institutional Clinical Trial New England Online Systems Operative Surgical Procedures Patient Monitoring Patient Recruitments Patients Persons Policies Population Principal Investigator Procedures Protocol Compliance Protocols documentation Publications Qualifying Quality Control Randomized Reading Reporting Research Research Institute Research Personnel Review Committee Risk Safety Site Site Visit Specimen Specimen Handling Staging Standards of Weights and Measures System Thrombopoietin Training Transfusion Treatment Efficacy Ultrasonography Writing adjudication clinical application cost cytokine data management design member patient safety symposium

项目摘要

DESCRIPTION (provided by applicant) The overall goal of the Transfusion Medicine/Hemostasis Clinical Trials Network (TMH CTN) is to conduct multi-center clinical studies to evaluate treatments and management strategies for children and adults with hemostatic disorders and methods of transfusion support for a variety of patient populations. The New England Research Institutes, Inc. (NERI) will continue to support the TMH CTN as Data Coordinating Center (DCC). The DCC has the following aims: 1) to collaborate in the selection, design, conduct, analysis and reporting of clinical studies and trials; 2) to develop a mechanism for patient recruitment and retention from out-of-network centers; 3) to manage protocol fund disbursement to both core and non-core sites; 4) to develop and maintain a data management system for each network study; 5) to institute quality control procedures including training site study personnel and conducting site visits; 6) to identify central laboratories and central review panels, and develop a system for tracking lab specimens and results; 7) to compile, edit, analyze and report study data; and 8) to coordinate the activities and meetings of the Steering Committee, and provide materials for PRC and DSMB members. During its first four years, the network has begun 3 clinical trials, and has 4 other studies nearing the final stages of development. These ongoing and planned studies include adjudication of specific clinical eligibility criteria and endpoints, a central ultrasound reading facility, and several central laboratories. The Transfusion Medicine/Hemostasis Clinical Trials Network will have an impact on the standard of care by investigating the efficacy, safety, and healthcare policy implications of treatment strategies in transfusion medicine and hematology. Conducting multicenter clinical trials within this network will provide sufficient subjects to evaluate important hypotheses regarding therapy and management in the respective patient populations. Study findings will be disseminated to the medical and scientific communities. The Transfusion Medicine/Hemostasis Clinical Trials Network plans and carries out studies in two areas of medicine. Transfusion Medicine studies investigate which patients need to be treated by giving transfusions, and which types and doses of transfusions to give. Hemostasis studies investigate disorders that put people at increased risk for serious bleeding or blood clots, and how to treat these disorders. DATA COORDINATING CENTER CRITIQUES

描述（由申请人提供）输血医学/止血临床试验网络 (TMH CTN) 的总体目标是进行多中心临床研究，以评估患有止血障碍的儿童和成人的治疗和管理策略以及针对各种患者群体的输血支持方法。新英格兰研究机构 (NERI) 将继续支持 TMH CTN 作为数据协调中心 (DCC)。 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) 制定从网络外中心招募和保留患者的机制； 3) 管理核心站点和非核心站点的协议资金支付； 4) 开发和维护每个网络研究的数据管理系统； 5）制定质量控制程序，包括培训现场研究人员和进行现场考察； 6) 确定中心实验室和中央审查小组，并开发跟踪实验室标本和结果的系统； 7）整理、编辑、分析和报告研究数据； 8) 协调指导委员会的活动和会议，并为 PRC 和 DSMB 成员提供材料。在最初的四年里，该网络已经开始了 3 项临床试验，还有 4 项其他研究已接近开发的最后阶段。这些正在进行和计划中的研究包括对具体临床资格标准和终点的裁决、中央超声读取设施和几个中心实验室。输血医学/止血临床试验网络将通过调查输血医学和血液学治疗策略的有效性、安全性和医疗保健政策影响，对护理标准产生影响。在该网络内进行多中心临床试验将提供足够的受试者来评估有关各自患者群体的治疗和管理的重要假设。研究结果将传播给医学界和科学界。输血医学/止血临床试验网络计划并开展两个医学领域的研究。输血医学研究调查哪些患者需要通过输血进行治疗，以及输血的类型和剂量。止血研究调查导致人们严重出血或血栓风险增加的疾病，以及如何治疗这些疾病。数据协调中心的批评