Re-Innovation in Clinical Trial Designs Based on Precision Therapy

Abstract

This article, centered on precision therapy, argues that traditional disease-centered clinical trials are flawed with prolonged cycles, insufficient early-phase samples, and inflexible protocols, thus proposing the concept of “clinical trial re-innovation.” It elaborates that this re-innovation, driven by biomarker technology, multi-arm multi-stage designs, and improved trial flexibility, is realized through innovative designs like basket, umbrella, and platform trials, and explores their application in multiple diseases with cases, aiming to advance precise and efficient clinical research and improve patient outcomes.