Transfusion Medicine/Hemostasis Clinical Trials Network-Data Coordinating Center

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，以评估患有止血疾病的儿童和成人的治疗和管理策略以及各种患者人群的输血支持方法。新英格兰研究所NERI将继续支持TMH CTN作为数据协调中心（DCC）。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）开发一种从网络外中心招募和保留患者的机制; 3）管理向核心和非核心研究中心支付的方案资金; 4）开发和维护每项网络研究的数据管理系统; 5）建立质量控制程序，包括培训研究中心人员和进行研究中心访问; 6）确定中心实验室和中心审查小组，并建立跟踪实验室样本和结果的系统; 7）汇编、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，另有4项研究接近开发的最后阶段。这些正在进行和计划进行的研究包括特定临床合格性标准和终点的裁定、中心超声阅读机构和几个中心实验室。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来影响护理标准。在该网络内进行多中心临床试验将提供足够的受试者，以评价有关各自患者人群治疗和管理的重要假设。研究结果将分发给医学和科学界。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输血治疗，以及输血的类型和剂量。止血研究调查使人们严重出血或血凝块风险增加的疾病，以及如何治疗这些疾病。 数据协调中心评论

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