Traumatic Brain Injury Clinical Trials Network-DCC

哥伦比亚大学已经组建了一个经验丰富的调查小组和工作人员与威廉T。弗里德瓦尔德， MD作为主要研究者，提供作为数据协调中心所需的专业知识和资源， 在RFA要求题为：合作多中心创伤性脑损伤临床试验网络。 长期以来，人们一直意识到创伤性脑损伤的主要和次要后果 (TBI)估计每年有5万人死亡，8万人终身残疾。研究兴趣有 专注于开发能够降低急性期死亡率的治疗方法， 神经损伤，这将改善那些幸存者的长期功能结果。为此， NICHD建议资助一个网站网络，这些网站将在急性和康复阶段进行临床试验， 创伤性脑损伤参与者将从美国最多8个临床研究中心招募，项目期为5年。的 网络指导委员会在设计和实施此类试验方面面临一些有趣的挑战，包括 需要1）建立统一的病例定义和护理标准，这些定义和标准将作为并将被统一接受为 为定量评价建议的干预措施提供依据，2）制定科学严谨、可行的 治疗急性TBI患者的方案，以及3）还开发另一种方案， 康复努力或更广泛的康复策略在创伤性脑损伤幸存者。这将需要发展 其中：i）临床研究中心工作人员的一般培训计划和颅内压管理，ii）复杂的， 基于网络的数据库，允许收集和管理试验数据，然后可以共享 在所有网络参与者之间，以及iii）试验基础设施， 新的研究方案为了应对这些设计和集成挑战，我们的提案提供了一个调查团队， 在关键岗位上有着非凡经验的人。其中包括私家侦探和他不同寻常的多样化临床试验研究 背景，高级统计学家，具有广泛的统计学经验和对临床试验研究的兴趣，数据 管理总监，拥有管理临床试验和其他研究的大型数据集的丰富经验 努力，最后是我们建议的临床咨询团队在TBI方面的临床和研究技能。 我们提案的总体目标是提供多个研究中心的协调、数据管理 以及分析和统计支助，使指导委员会和 NICHD成功整合网络站点并成功完成拟议的临床试验。

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 Trials Network. There has been long standing awareness of the primary and secondary consequences of traumatic brain injury (TBI) with an estimated 50,000 deaths 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 minimze 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 period of 5 years. The Network Steering Committee faces some interesting challenges in designing and implementing such trials, including the need 1)to establishuniform 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 rehabilitationstrategies in the survivors of TBI. This will require the development of: i) training programs for the clinical site staffs generally and in the management of intracranial pressure, ii) a complex, web-based database that will allow the collection and management of data from the trials and 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 our proposal offers a team of investigators with unusually experienced people in the key positions. These include the P.I.with his unusally diverse clinical trial research background, the Senior Statistician with his broad statistical experience and interest in clinical trial research, the Data Management Director with his extensive experience managing large data sets from clinical trials and other research efforts, and finally the clinical and research skills in TBI of our proposed clinical advisory team. The overall goal of our 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 successfullyintegrate the Network sites and successfullycomplete the proposed clinicaltrials.