Strategic Approach

Translating Science to Success

Recent advances in stroke and TBI management and our ability to characterize these conditions have reopened doors to exploring previously untapped therapeutic approaches.

  • Standardized clinical trial pathways and efficacy endpoints (g., increases in serum biomarkers associated with severity of injury) enable targeting of homogeneous subpopulations.
  • Health care system infrastructure and technology advances (accreditation, triage, diagnostics, imaging, mobile stroke units, telemedicine) are enabling faster diagnosis and treatment within the window for effective use of tissue plasminogen activator (tPA).
  • For Stroke patients, removal of clots by mechanical thrombectomy (MT) – a procedure gaining traction since 2015 – restores perfusion effectively in some patients, enabling neuroactive drugs to reach compromised brain tissue.

How can advances in stroke & TBI research inform better clinical trial design and execution?

Hover over the images below to learn how TBI research improves clinical trial design.

Patient Identification

In Stroke: Identification through Computed Tomography Angiography (CTA) and Computed Tomography Perfusion (CTP)

In TBI: Enriched Patient Selection via biomarkers, Phenotyping, Stratification

Therapeutics

Discovery of Therapeutic Agents Targeting Brain Pathologies, Mechanisms

Measurement

Deployment of Improved Methods to Measure Recovery, Response to Treatment, Outcomes

New Horizons in Brain Injury Medicine

Hover over the images below to learn more about new horizons in brain injury medicine.

Natural History

of Injury &

Recovery

Data from large, prospective, longitudinal studies informing the acute effects, recovery, and persistent impairments after TBI.

Targeted Drug Development & Intervention

Therapeutics targeting specific pathophysiological mechanisms of TBI. Design of clinical trials adapted to targets, trajectory and timing for intervention.

Patient

Selection &

Stratification

Enhanced patient enrichment and characterization of injury through improved brain injury classification and objective assessment of serum biomarkers associated with stroke/TBI severity.

Protocol Development & Execution

Precision design of protocols for maximum detection of acute signal and treatment effects at high-volume, high performing TBI centers.

Measuring

Outcome &

Response to Rx

Data-informed selection of primary, secondary, exploratory endpoints to measure clinical and biological response to treatment.