Funded by NICHD



The NICHD Traumatic Brain Injury Clinical Trials (TBI-CT) Network consists of a team of academic clinical centers and a data coordinating center, as well as the National Center for Medical Rehabilitation Research at the National Institute of Child Health and Human Development. The five clinical centers: Temple University, University of Alabama at Birmingham, University of Pittsburgh, University of Washington and Virginia Commonwealth University (as of September 2002), have agreed to investigate problems in Traumatic Brain Injury in a collaborative manner. The clinical centers represent premier institutions in TBI medicine with track records of excellence in clinical research. The data coordinating center was selected on the basis of their experience with the coordination of multi-center clinical trials, and with proven expertise in study design, data management and biostatistical analysis. The Data Coordinating Center (DCC) for the Network is the Columbia University Department of Biostatistics.

There are many unique and complex challenges involved in designing, implementing, and monitoring high quality multicenter research initiatives. Research design and methodology, staff resources, study participant retention, data collection and analysis, training and research capacity building, quality control, fiscal accountability, and cost-effectiveness are just a few of the hurdles involved with a cooperative network. The cooperative agreement mechanism provides an infrastructure by which multidisciplinary staff can efficiently develop and implement multiple, complex, research projects simultaneously and disseminate information and research results.

Overall program management and stewardship responsibility for review and oversight of the cooperative agreement resides with the NICHD. However, additional governing bodies have been established to provide in-depth scientific evaluation and support of the program.

The TBI-CT Network is overseen by three governing bodies:

  1. Steering Committee;

  2. Data and Safety Monitoring Committee (DSMC);and

  3. Advisory Board