BRAIN TRAUMA FOUNDATION

We constantly seek to improve the diagnosis and treatment of TBI. To do this, we lead the way in cutting-edge clinical research spanning the spectrum from concussion to coma. We partner with some of the most prestigious organizations, such as the United States Department of Defense, Stanford University, Oregon Health and Sciences University, and Portland State University, on research. This work ranges from looking at the use of quantitative measurements via virtual reality eye tracking to better assess concussions, to being part of a multi-institutional research consortium that seeks to provide a stronger evidence base for brain injury research.

Clinical Trials in TBI
Failure to establish intervention effectiveness for brain trauma in clinical trials is a primary feature of the current condition of our work. Fourteen years ago the Clinical Trials in Head Injury Study Group published a thoughtful summary of recommendations to improve the design and conduct of clinical trials in TBI. They encouraged (in part):

• Identification and testing of specific (appropriate) subgroups of TBI patients
• Standardized clinical management across centers
• Independent monitoring of patient management and data quality
• Parsimonious data collection
• Identification of relevant outcome measures and adequate time to follow-up, and
• Identification of clinically relevant effect size.

A useful exercise might be to examine the extent to which our community is adhering to these recommendations, and to fundamental tenets of evidence-based medicine, in the design and conduct of our current work.

New Research Approaches
It is reasonable to consider how different research designs might be used to identify which treatments work best, for whom, and under what circumstances. This is the possibility of Comparative Effective Research (CER), which is being promoted by funding agencies and adopted by large consortium efforts in the brain trauma research community. However, CER is still subject to many of the same vulnerabilities at the operational level, because it is accomplished using randomized controlled trials (RCTs) and observational studies. A transition to a new focus on CER must be accompanied by consistent adherence to evidence-based protocols.

Collaborations
There is a need for investigators to work together, share data, and pool resources in order to improve our efficiency at finding answers. Currently, funding agencies are requiring collaborative efforts among their grantees as a prerequisite to funding. In our efforts to successfully collaborate, we need to account for institutional barriers to financial collaborations, and for barriers in the mechanics of collaborations. Pooling data into large repositories requires resources, time, and cooperation across investigators, institutions, and disciplines that often exceed the scope of the project. Building the platform for the repository becomes the deliverable, rather than using the platform to enable answering the questions.