Integrating Virtual Reality into the Assessment of Functioning in Clinical Trials

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

VRFCAT is a Pathway-based task that simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to basic functional capacity deficits, the VRFCAT was developed to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric and regulatory standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.

The VRFCAT has officially been accepted into the FDA’s COA Qualification Program as a measure of functional capacity for schizophrenia treatment trials. This FDA program is intended to qualify drug development tools that can be relied on to have a specific interpretation and application in any drug development program and regulatory review. VeraSci also received an FDA grant to conduct further research on the VRFCAT.

Advantages of the VRFCAT:

  • Scientifically validated
  • Accurate, performance-based results
  • Integrated data capture
  • Alternate forms for repeated testing
  • Eases administrator burden
  • Well-tolerated by patients
  • Available in multiple languages and culturally adapted environments
  • Fast, responsive 24/7 technical support
  • FDA 21 CFR Part 11 Compliant