Challenges and opportunities in traumatic brain injury clinical trials

As traumatic brain injury (TBI) becomes more prevalent in the global population due to advancements made in its diagnosis, it is emerging as a major cause of disability and death, as well as a burden on healthcare systems and economies. TBI — a form of acquired brain injury that occurs when trauma causes damage to the brain — can occur as a result of vehicle collisions, falls, recreational activities, exposure to explosive blasts and participation in athletics. Evidence suggests that TBI may also be a risk factor for later neurological and neurodegenerative disease — such as Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis.

The manifestations and effects of TBI are varied and impact diverse populations. To improve prevention and therapy, we need to conduct further clinical research to evaluate and validate better strategies for diagnosis and disease characterisation. A better understanding of how TBI — mild and severe — manifests, can lead to better identification of biomarkers, and the development of prevention and treatment strategies. In this whitepaper, we:

• Describe the impact of TBI on different populations including military personnel, athletes, the elderly and adolescents
• Explore the challenges and opportunities in TBI clinical research
• Build a case for the broader adoption of patient centricity and virtual trials in TBI research
• Outline how to best harness devices, diagnostics, digital endpoints and data strategy in TBI studies