Large-scale study to bring precision medicine to traumatic brain injury treatment

As part of an international collaboration aimed at developing more targeted treatments for traumatic brain injury (TBI) and reducing its public health burden, a pan-European observational study has finished data collection, with clinical support from Icon.

The project, dubbed the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI), is an observational study designed as a comparative effectiveness research.

From December 2014 to October 2017, the European Commission-funded core study enrolled and collected detailed data from 4,500 patients at 65 sites in 20 European countries, while basic data from over 26,000 patients have been entered into the registry. Icon provided remote and onsite monitoring and source data verification services amounted to over 13,000 data points.

“Advances in genomics, blood biomarkers, magnetic resonance imaging (MRI), and pathophysiological monitoring, combined with informatics to integrate data from multiple sources” could assist better understanding of TBI, which could lead to more targeted treatments, wrote The Lancet Neurology Commission on TBI, which just launched.

With the help of Icon and over 150 researchers, CENTER-TBI has obtained detailed data on illness details, treatment and outcome, as well as costs, with the aim to better characterize TBI, increase prognostic accuracy and understand benefits of various treatments on different patients so that a precision medicine approach could be developed.

“We are reaching the end of data collection and entering the analysis phase,” Prof. Andrew Maas from the University Hospital Antwerp, who co-leads the study with Prof. David Menon from the University of Cambridge, announced during a research meeting in September, as quoted by a Lancet Neurology article. The project is now expected to conclude in 2020.

CENTER-TBI is only the European chapter of a cooperative effort called the International Initiative for Traumatic Brain Injury Research (InTBIR) set up in October 2011. Besides the European Commission, the National Institutes of Health and the Canadian Institutes of Health Research are also coordinating the effort, which involves research projects in Europe, the U.S., Canada, Australia, China and India.

CENTER-TBI puts the number of annual European TBI cases at 2.5 million people, including 75,000 deaths. The annual financial burden of TBI in the U.S. has been estimated at over $60 billion, according to the project. Though the exact global incidence of global TBI injuries is difficult to quantify, researchers estimate that it could be more than 50 million.

The Commission on TBI has already identified 12 recommendations and policies to improve the prevention, quality of care and clinical research in TBI. It also advocates for new directions for acquiring and implementing clinical evidence, so that it can in return be used to guide clinical care, which is important because the epidemiology of TBI is constantly changing.

“Improved, accurate epidemiological monitoring and robust health-economic data collection are needed to inform healthcare policy and prevention programs,” the Commission said. Maas, in a statement, described InTBIR as an unparalleled opportunity to pioneer new approaches to research, including the creation of a “living evidence base.”