Steven Stone, PhD, presents “UroVision Interview – Simon Criteria for Biomarkers in Urologic Oncology.”

How to cite: Stone, Steven. “UroVision Interview – Simon Criteria for Biomarkers in Urologic Oncology.” February 19, 2025. Accessed Jun 2025. https://grandroundsinurology.com/urovision-interview-simon-criteria-for-biomarkers-in-urologic-oncology-2/

UroVision Interview – Simon Criteria for Biomarkers in Urologic Oncology – Summary

What You Will Learn in This Program:

In this 12-minute expert discussion, Steven Stone, PhD, EVP of Research and Development at Envision Sciences, joins E. David Crawford, MD, Editor in Chief of Grand Rounds in Urology, to explore how the Simon criteria can be applied to the validation of prognostic and predictive biomarkers, with a focus on urologic oncology.

By watching this program, you will:

  • Understand the role of randomized clinical trials (RCTs) in biomarker validation
    • Learn why RCTs remain the gold standard for predictive biomarkers, but may not always be necessary for validating prognostic biomarkers.
  • Gain insight into alternative real-world validation approaches
    • See how rigorously designed observational cohorts, with prospective protocols and well-defined endpoints, can provide strong external validity for prognostic tests.
  • Learn how biomarker evidence should be evaluated for clinical guidelines
    • Dr. Stone discusses why rigid adherence to the Simon criteria may not always serve guideline committees and makes the case for more flexible, holistic evidence assessments similar to FDA practices.
  • Recognize when randomization is critical in late-stage biomarker development
    • Understand how randomized studies can demonstrate clinical utility by confirming that risk stratification improves patient outcomes, reduces morbidity, or optimizes healthcare resources.
  • Appreciate the nuances of prognostic vs predictive biomarker development
  • Learn the key differences in how these biomarkers inform clinical decisions and how they should be evaluated throughout their development pathway.

This session provides valuable perspective for anyone involved in biomarker development, clinical research, guideline development, or the application of precision medicine in urologic cancer care.