Traumatic Brain Injury Clinical Trials Network-DCC

创伤性脑损伤临床试验网络-DCC

• 批准号: 6655085
• 负责人: WILLIAM T FRIEDEWALD
• 金额: $ 107.17万
• 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/6655085
• 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）：哥伦比亚大学组建了一支经验丰富的研究人员和工作人员团队，以 William T. Friedewald 医学博士为首席研究员，按照 RFA 题为“合作多中心创伤性脑损伤临床试验网络”的要求，提供充当数据协调中心所需的专业知识和资源。 人们长期以来一直认识到创伤性脑损伤 (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能够显着降低急性期死亡率、最大限度地减少继发性神经损伤并改善幸存者的长期功能结果的疗法。 为此，NICHD 提议资助一个站点网络，该网络将在 TBI 的急性期和康复期进行临床试验。 参与者将从美国多达 8 个临床中心招募，项目为期 5 年。 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，作为对拟议干预措施进行定量评估的基础，并被一致接受，（2）制定科学严格且可行的治疗方案，用于急性创伤性脑损伤患者的治疗，（3）还制定另一项方案，以评估具体的康复工作或治疗方案。 TBI 幸存者更广泛的康复策略。 这将需要制定（i）针对临床现场工作人员和颅内压管理的培训计划，（ii）一个复杂的基于网络的数据库，该数据库将允许收集和管理试验数据，然后可以在所有网络参与者之间共享，以及（iii）一个能够添加新研究方案的试验基础设施。 为了应对这些设计和集成挑战，该提案提供了一个研究团队，其中包括一名 P.I.具有多元化的临床试验研究背景，具有丰富的统计经验并对临床试验研究感兴趣的高级统计学家，具有管理临床试验和其他研究工作的大数据集的丰富经验的数据管理总监，以及具有 TBI 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中心、数据管理和质量控制活动以及分析和统计支持，使指导委员会和 NICHD 能够成功整合网络中心并成功完成拟议的临床试验。