Traumatic Brain Injury Clinical Trials Network-DCC

创伤性脑损伤临床试验网络-DCC

• 批准号: 6919264
• 负责人: WILLIAM T FRIEDEWALD
• 金额: $ 106.88万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-05 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6919264
• 关键词: Internet; biomedical facility; brain injury; clinical research; clinical trials; cooperative study; data collection methodology /evaluation; data management; experimental designs; human data; information systems; medical rehabilitation related tag; rehabilitation; statistics /biometry; trauma

DESCRIPTION (provided by applicant): Columbia University has assembled an experienced team of investigators and staff with William T. Friedewald, MD as Principal Investigator to provide the expertise and resources necessary to serve as the Data Coordinating Center as requested in the RFA entitled "Cooperative Multicenter Traumatic Brain Injury Clinical Trails Network." There has been long standing awareness of the primary and secondary consequences of traumatic brain injury (TBI) with an estimated 50,000 death annually and 80,000 people permanently disabled. The research interest has focused on developing therapies that will reduce the significant acute phase mortality, that will minimize the secondary neurological injury, and that will improve the long-term functional outcome of those who survive. To these ends the NICHD proposes to fund a Network of sites that will undertake clinical trials in both the acute and rehabilitation phases of TBI. The participants will be recruited from up to 8 clinical sites in the United States with a project of 5 years. The Network Steering Committee faces some interesting challenges in designing and implementing such trials, including the need (1) to establish uniform case definitions and standards of care that will serve as, and will be uniformly accepted as, a basis for the quantitative evaluation of the proposed interventions, (2) to develop a scientifically rigorous and feasible protocol for treating people acutely with TBI, and (3) to also develop another protocol that will evaluate either specific rehabilitation efforts or more broadly rehabilitation strategies in the survivors of TBI. This will require the development of (i) training programs for the clinical site staffs generally and for the management of intracranial pressure, (ii) a complex, web-based database that will allow the collection and management of data from the trials that can then be shared among and between all of the Network participants, and (iii) an infrastructure for the trials that will enable the addition of new research protocols. To meet these design and integration challenges, this proposal offers a team of investigators that includes a P.I. with a diverse clinical trial research background, a Senior Statistician with broad statistical experience and interest in clinical trials research, a Data Management Director with extensive experience managing large data sets from clinical trials and other research efforts,and an advisory team with clinical and research skills in TBI. The overall goal of the proposal is to provide the coordination of the multiple study sites, the data management and quality control activities, and the analytical and statistical support that will enable the Steering Committee and the NICHD to successfully integrate the Network sites and successfully complete the proposed clinical trials.

描述(由申请人提供)：哥伦比亚大学已经组建了一支经验丰富的调查人员和工作人员团队，由医学博士William T.Friedewald担任首席调查员，以提供必要的专业知识和资源，以充当RFA中题为“合作多中心创伤性脑损伤临床试验网络”中所要求的数据协调中心。 长期以来，人们一直意识到创伤性脑损伤(TBI)的主要和次要后果，估计每年有50,000人死亡，80,000人永久残疾。研究兴趣集中在开发治疗方法，以降低显著的急性期死亡率，将继发性神经损伤降至最低，并将改善存活者的长期功能结果。为此，NICHD提议资助一个场地网络，该网络将在脑损伤的急性期和恢复期进行临床试验。参与者将从美国最多8个临床地点招募，项目为期5年。网络指导委员会在设计和实施这类试验时面临一些有趣的挑战，包括：(1)需要(1)建立统一的病例定义和护理标准，作为对拟议干预措施进行量化评估的基础，(2)制定科学上严格可行的方案，对脑外伤患者进行急性治疗；(3)还需要制定另一种方案，对脑外伤幸存者的具体康复努力或更广泛的康复战略进行评估。这将需要开发(I)临床现场工作人员的一般培训计划和管理颅内压，(Ii)一个复杂的基于网络的数据库，它将允许收集和管理来自试验的数据，然后可以在所有网络参与者之间共享这些数据，以及(Iii)试验的基础设施，将能够增加新的研究方案。为了应对这些设计和集成挑战，本提案提供了一个调查团队，其中包括一名具有不同临床试验研究背景的私人助理、一名具有广泛统计经验并对临床试验研究感兴趣的高级统计师、一名具有管理临床试验和其他研究工作的大型数据集的丰富经验的数据管理总监，以及一支在TBI方面具有临床和研究技能的顾问团队。 该提案的总体目标是协调多个研究站点、数据管理和质量控制活动以及分析和统计支助，使指导委员会和排雷中心能够成功整合网络站点并成功完成拟议的临床试验。