In recent years,investment in new drug development in China has surged;however,challenges such as difficulties in efficacy validation,high failure rates,and lengthy,costly clinical trials have been faced.The traditional model is insufficient for addressing these issues,necessitating innovation.Adaptive design(AD),particularly sequential multiple assignment randomized trials(SMART),has emerged as a flexible and efficient new pathway for drug development.This study focused on the two-stage design of SMART,analyzed its principles,and contrasted it with randomized controlled trials,group sequential designs,and crossover designs.The advantages of SMART are highlighted in terms of its precision in evaluating treatment strategies,minimizing sample waste,and enhancing the exploration of complex treatment pathways.Through case analyses,we demonstrated that SMART significantly improved clinical trial efficiency and the quality of treatment decisions,representing an innovative solution to the challenges of new drug development.This study aims to provide strategic references for clinical researchers and promote the adoption of adaptive designs in China,facilitating the efficient advancement of new drug development.
维普
万方数据