Cross-sectional analysis of data from the U.S. clinical trials database reveals poor translational clinical trial effort for traumatic brain injury, compared with stroke.

Lucia M Li,David K Menon,Tobias Janowitz,Hooman Kamel

doi:10.1371/journal.pone.0084336

Lucia M Li, David K Menon + Show 2 more

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https://doi.org/10.1371/journal.pone.0084336

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Abstract

Traumatic brain injury (TBI) is an important public health problem, comparable to stroke in incidence and prevalence. Few interventions have proven efficacy in TBI, and clinical trials are, therefore, necessary to advance management in TBI. We describe the current clinical trial landscape in traumatic brain injury and compare it with the trial efforts for stroke. For this, we analysed all stroke and TBI studies registered on the US Clinical Trials (www.clinicaltrials.gov) database over a 10-year period (01/01/2000 to 01/31/2013). This methodology has been previously used to analyse clinical trial efforts in other specialties. We describe the research profile in each area: total number of studies, total number of participants and change in number of research studies over time. We also analysed key study characteristics, such as enrolment number and scope of recruitment. We found a mismatch between relative public health burden and relative research effort in each disease. Despite TBI having comparable prevalence and higher incidence than stroke, it has around one fifth of the number of clinical trials and participant recruitment. Both stroke and TBI have experienced an increase in the number of studies over the examined time period, but the rate of growth for TBI is one third that for stroke. Small-scale (<1000 participants per trial) and single centre studies form the majority of clinical trials in both stroke and TBI, with TBI having significantly fewer studies with international recruitment. We discuss the consequences of these findings and how the situation might be improved. A sustained research effort, entailing increased international collaboration and rethinking the methodology of running clinical trials, is required in order to improve outcomes after traumatic brain injury.

Highlights

Traumatic Brain Injury (TBI) and stroke both have major public health impacts
Descriptive data of the enrolment for these studies are presented below and study characteristics are presented for the 1168 stroke and 268 TBI interventional studies found within the completed search (Figure 1)
The research effort in stroke is substantially greater than TBI, as measured by the total participant enrolment number, the total number of studies and the number of interventional studies (Fig. 2)

Summary

Introduction

Traumatic Brain Injury (TBI) and stroke both have major public health impacts They are common causes of brain injury, which present acutely and result in long-term personal and social consequences. The US prevalence for stroke and TBI are 6.8 million and 5.3 million, and the annual incidence are 800 000 and 1.6 million for stroke and TBI respectively [3,4,5,6] Both conditions, but TBI in particular, are associated with a wide range of physical, cognitive and psychological deficits, which persist for years after injury [7,8,9,10,11,12,13]. Health economic estimates suggest that TBI accounts for over $70 billion (range $48– 72 billion) in direct (e.g. long-term burden of medical care) and indirect (e.g. loss of productivity in a working population) costs in the USA annually [4,22,23], which is comparable to the estimated annual costs of stroke (range $38–74 billion) [24,25]

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