The FY19 PH/TBIRP CTRR-CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of complex TBI.
Clinical trials may be designed to evaluate promising products, pharmacologic agents (drugs or biologics), devices, clinical
guidance, and/or emerging approaches and technologies.
Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0) to demonstrate feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.
TBI is defined as being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain.
Not all blows to the head or exposure to external forces result in a TBI.
The severity of TBI may range from “mild,” a brief change in mental status or consciousness, to “severe,” an extended period of unconsciousness or confusion after the injury.
A complex TBI is a multi-faceted condition resulting after mTBI with comorbidities and related deficits in the areas of cognition, sensorimotor, and performance.
Classification of TBI severity can be found in Table 1 of the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury.
The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.
Funding from this award mechanism must support a clinical trial.
New FY19 definition:
A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.