• 1. Second Affiliated Clinical School, Guangzhou University of Chinese Medicine, Guangzhou 510403, P. R. China;
  • 2. Basic Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510006, P. R. China;
  • 3. School of Life Sciences, Ningxia University, Yinchuan 750021, P. R. China;
  • 4. Institute of Clinical Basic Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
  • 5. Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510120, P. R. China;
CHEN Xinlin, Email: chenxlsums@126.com
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In recent years, investment in new drug development in China has surged; however, it faces challenges such as difficulties in efficacy validation, high failure rates, and lengthy, costly clinical trials. The traditional model is insufficient to address these issues, necessitating innovation. Adaptive designs (AD), particularly sequential multiple assignment randomized trials (SMART), have 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 were highlighted in terms of its precision in evaluating treatment strategies, minimizing sample wastage, 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, thereby facilitating the efficient advancement of new drug development.