What EBIC can offer
Traumatic brain injury is a disease with one of the highest unmet medical needs, and is the leading cause of death and disability among young adults. TBI accounts for more potential years of life lost than cancer and cardiovascular disease combined. Not only does TBI lead to great personal suffering and family disruption, but poses a significant burden to society with direct and indirect costs in the United States alone being estimated at over $ 6 billion per year. None of us is exempt from the risk for neurotrauma at any age, extending from battering during infancy, through sports injuries and traffic accidents during adolescence and young adulthood, to an increased risk of injuries from falls as we age. Prevention and awareness of risks remain top priorities. Research has greatly advanced our understanding of neurotrauma, and treatment results have improved following the establishment of an appropriate trauma organization and implementation of guidelines. Bench research has identified various strategies with neuroprotective potential to reduce secondary injury, and new insights hold promise for enhancing recovery. Yet, there is no cure for neurotrauma. The tremendous personal suffering and tragedy, and the high socio-economic costs associated with neurotrauma, call for immediate and extensive research efforts to further increase our understanding of the disease and to improve treatments. This can only be accomplished with adequate funding and by collaboration between clinical/basic researchers and pharmaceutical companies. It is here that EBIC provides a platform for advancing our knowledge with the aim of reducing the burden of neurotrauma and improving treatment results and quality of life in individual patients.
for centers and investigators:
EBIC is dedicated to promoting research in brain injury in collaborating member centers and is happy to advise on and support research proposals. Proposals from pharmaceutical companies are carefully evaluated by the Executive and studies with the best potential endorsed. EBIC sites with a good potential for participating and specific research proposals are nominated to the sponsor. In this way EBIC strives to promote high quality research in brain injury.The consortium should have a major input in:
- The development of a coherent set of trial protocols covering the various therapeutic options under development. They should be optimal in terms of clinical relevance, data collection, reliability and independent statistical analysis.
- The choice of agents that are potentially most beneficial clinically.
- The design of case record forms.
- The development of a standardized set of core data over all consortium trials (which should be compatible with that being developed by the American Brain Injury Consortium).
- The establishment of criteria for outcome assessment.
- Independent statistical analysis.
- Rigorous interpretation and publication of results.
for pharmaceutical companies and research organizations:
What EBIC can offer to pharmaceutical companies and research organizations:
- Assist and advise on protocol development.
- Provide members, with sponsor, for study steering committee, safety committee and other sub committees.
- Suggest principal investigator(s).
- Identify and evaluate potential sites.
- Center inspection, training, quality control.
- Monitoring progress of study by collection and analysis of screening logs in EBIC coordinating center. Liaison with centers/newsletter. Assist in arranging investigators meetings.
- Deal with medical inquiries.
- Review of data for quality, consistency, credibility.
- Central review of CT scans and outcome assessment.
- Analysis and interpretation of results of study. Review of study report.
- Prepare papers for publication.