The changing landscape of traumatic brain injury research.

As this issue of The Lancet Neurology went to press, the guidelines for the management of patients in different traumatic brain injury (TBI) research community was settings have been developed, many of these recomeagerly anticipating an imminent call for proposals from mendations are not backed up by high-quality evidence. the European Commission (EC). The new funding— Clinical care and patients’ outcomes vary greatly from expected to be included in the EC 7th Framework centre to centre and in different countries. For instance, Programme (FP7) for cooperative health research—will a recent study found large between-centre differences in be the first economic support from the EC for a unique clinical outcomes (about three times higher than expected research effort: the International Initiative for Traumatic by chance) even in the setting of large multicentre clinical Brain Injury Research (InTBIR). This initiative, which will trials. Hence, approaches to measure this variability in also be supported by the Canadian Institutes of Health management and its effects on prognosis are urgently Research and the US National Institutes of Health, is an needed. Analyses of high-quality, large, observational international multidisciplinary collaborative endeavour data sets by use of CER statistical methods could provide that aims to rapidly improve clinical practice in TBI. specific answers on effective management more quickly— A coordinated effort to boost TBI research by the and more cheaply—than will traditional clinical trials. major funding agencies of neurological research in There is also an urgent need for comparative studies on North America and Europe was long overdue. TBI is an the effects of access to acute and post-acute care, and it enormous public health problem, across all ages, and is unlikely that adequately powered clinical trials could in all populations; even in North America and Europe, be implemented soon to address these uncertainties where TBI incidence is lower than in poorer regions, across different settings. But by use of carefully designed it has been estimated at 150 to 300 cases per 100 000 collection methods, high-quality harmonised data, and population per year. Over 200 per 100 000 individuals prospective definition of any analyses plans, the InTBIR with TBI are admitted to European hospitals each year, should enable researchers to learn more about the aswith an average in-hospital case-fatality rate of 3%; sociations between management and clinical outcomes in the USA, the average rate is 6·2%, and estimates and improve prognostic models. indicate that 1–2% of the population live with disability As the journal went to press, the participating funding caused by TBI. According to WHO, because incidence is agencies were preparing a document describing the increasing swiftly in low-income and middle-income specific goals and strategy of the InTBIR, its detailed countries (mostly owing to road traffic accidents), TBI governance, and the rules for participation; this document is predicted to become the third leading cause of global will be publicly available before the end of the year. Other mortality and disability by 2020. Furthermore, evidence funding agencies and philanthropists wishing to support suggests that TBI is a risk factor for dementia, substance the aforementioned goals of improved outcomes and abuse, and other psychiatric disorders. However, few decreased disease burden might be given the opportunity improvements in clinical outcomes for patients with to contribute; the initiative should also attract the TBI have been achieved over the past two decades, and interest of the pharmaceutical industry, because the no effective therapy for TBI has been approved by any characterisation of patients with TBI will be key to regulatory agency. development of effective therapies. A sizeable economic The InTBIR will gather the evidence that could lead to effort will indeed be required: the EC FP7 call for proposals the improvement of patients’ outcomes and decrease the is expected to offer only €30 million, a meagre sum that global burden of TBI by 2020. These goals will be achieved will fall short of that needed to implement the InTBIR by implementing a plan with three major components: across Europe. For the initiative to succeed, all interested the standardisation of data collection, the creation of stakeholders worldwide (TBI researchers, global health an open-source registry to share the data, and the repolicy makers, funding agencies, and industry) have to orientation of research questions by shifting towards support it and get involved—the possibility to tackle a comparative effectiveness research (CER) approach. this crucial global health problem by 2020 should not be TBI is a heterogeneous and complex disorder; although missed. ■ The Lancet Neurology For more on EC funding and InTBIR see http://ec.europa.eu/ research/health/medicalresearch/brain-research/ international-initiative_en.html