Traumatic Brain Injury Clinical Trials Network-DCC

哥伦比亚大学与威廉·T·弗里德瓦尔德组建了一支经验丰富的调查团队和工作人员， MD作为首席调查员，提供必要的专业知识和资源，作为数据协调中心 在题为：合作多中心创伤性脑损伤临床试验网络的RFA中要求。 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 据估计，每年有50,000人死亡，80,000人永久残疾。研究兴趣主要集中在 专注于开发治疗方法，以降低显著的急性期死亡率，从而最大限度地减少继发性 神经损伤，这将改善那些幸存者的长期功能结果。为达到这些目的， NICHD提议资助一个地点网络，在急性和康复阶段进行临床试验 TBI。参与者将从美国最多8个临床地点招募，项目期限为5年。这个 网络指导委员会在设计和实施此类试验时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，作为并将被统一接受为 为拟议干预措施的量化评估奠定基础，2)制定科学严谨、可行的 用于尖锐地治疗脑外伤患者的协议，以及3)还开发另一种协议，该协议将评估任何一种特定的 颅脑损伤幸存者的康复努力或更广泛的康复策略。这将需要发展 I)临床现场工作人员的总体和管理颅内压的培训方案，ii)综合体， 基于Web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和之间，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，我们的提案为调查团队提供了 在关键岗位上拥有非凡经验的人。其中包括P.I.及其非同寻常的多样化临床试验研究 背景，这位高级统计学家凭借他广泛的统计经验和对临床试验研究的兴趣，提供了 管理总监，具有管理来自临床试验和其他研究的大型数据集的丰富经验 最后，我们建议的临床咨询团队在TBI方面的临床和研究技能。 我们建议的总体目标是提供多个研究地点的协调、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 NICHD成功地整合了网络站点，并成功完成了拟议的临床试验。

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.