A Problematic Biomarker Trial Design
Boris Freidlin, Edward L. Korn
Abstract
Efficient biomarker-driven randomized clinical trials are a key tool for implementing precision oncology. A commonly used biomarker phase III design is focused on testing the treatment effect in biomarker-positive and overall study populations. This approach may result in recommending new treatments to biomarker-negative patients when these treatments have no benefit for these patients.
Topics & Concepts
BiomarkerMedicineRandomized controlled trialOncologyClinical trialInternal medicineBiologyBiochemistryCancer Immunotherapy and BiomarkersCancer Genomics and DiagnosticsRadiomics and Machine Learning in Medical Imaging