Mild TBI (mTBI) is estimated to account for 80-90 percent of the TBI cases but is now being recognized as a major public health crisis. First, most mTBI patients seem to make a complete recovery which makes early identification of patients who are likely to develop persistent symptoms or neuropsychological deficits difficult.
Secondly, because mortality for people with mTBI is rare, the diagnostic assessments commonly used in more severely injured patients are not sensitive enough to assess the subtle cognitive, and behavioral issues often resulting from mTBI.
A discussion paper released at the FDA www.fda.gov workshop “Advancing the Development of Biomarkers in Traumatic Brain Injury” (TBI) emphasizes the need for biomarkers for mTBI. Establishing biomarkers could improve diagnostic capabilities but also enable more productive clinical trials to support the development and approval of medical products.
According to the discussion paper, although well-designed clinical trials have been conducted, they have failed to demonstrate clinically meaningful outcomes. This stems in part from our inability to precisely diagnose this multi-factorial condition to being able to accurately define patient selection criteria for clinical trials that are based on injury characteristics and are able to reliably measure the effects of treatments over time.
FDA wants to engage stakeholders in discussions on the scientific and clinical considerations associated with the analytical and clinical validation of all categories of TBI markers. These categories of biomarkers include 1) susceptibility/risk biomarkers, 2) diagnostic biomarkers, 3) monitoring biomarkers, 4) prognostic biomarkers, 5) predictive biomarkers, 6) pharmacodynamics/response biomarkers, and 7) safety biomarkers.
If you have information on this topic that you wish FDA to consider, go to www.fda.gov/RegulatoryInformation/Dockets/Comments/ucm089193.htm. Go to www.fda.gov/downloads/medicalDevices/NewsEvents/WorkshopsConferences/ucm488332.pdf to view the discussion paper released at the March 3 workshop.