Cooperative Multicenter TBI Clinical Trials Network-DCC

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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.