Exploration and Reflections on the Application of Platform Trials in Clinical Research of Chinese Medicine
Platform trial is a clinical trial design model that simultaneously evaluates multiple treatment options within a single trial framework while allowing flexible adjustments during the trial to improve efficiency and optimize resources.The advantages of platform trials include facilitating the comparison of various interventions,reducing downtime between trials,and enabling long-term,dynamic evaluations of the optimal intervention for a specific disease.This article introduces the concept,principles,and methodological key points of platform trials,compares their design differences,advantages,and disadvantages with traditional clinical trials,and provides an in-depth analysis of the practical application of platform trials through the systematic therapy for advanced or metastatic prostate cancer:evaluation of drug efficacy(STAMPEDE)trial case.Additionally,it explores the potential advantages,challenges,and feasibility of applying platform trials in clinical research of Chinese medicine(CM)to promote innovation and development in CM clinicalresearch.
platform trialsmaster protocolmethodologyChinese medicineclinical research