Randomization was the basis for the design and conduct of clinical trials. However, the traditional randomized controlled trials (RCTs) were often randomized in a fixed manner with unbalanced potential covariates, which spured researchers to develop a more flexible and practical randomization method. Thus, the adaptive randomization emerged as the time needed. In this paper, the application of adaptive randomization in clinical trials was introduced, and its key points of implementation, advantages and disadvantages were summarized. The development space of the adaptive randomization in clinical applications was also discussed, and it provided evidence for the development of the drug clinical trials in China.
In the context of increasingly stringent clinical trial quality control, the establishment of Data Monitoring Committees (DMCs) has become essential for ensuring scientific rigor and ethical compliance. As a key tool for DMC decision-making, interim analysis reports play a critical role in assessing trial safety and efficacy. However, current DMC reports often exhibit significant shortcomings, such as complexity, lack of logical structure, data redundancy, and limited practical utility. These issues hinder effective risk-benefit evaluations required by regulatory standards. This paper identifies and analyzes these deficiencies and their associated risks, aiming to provide actionable recommendations for developing systematic, concise, and accurate DMC reports. Such improvements will support DMCs in making informed, scientifically sound decisions while enhancing the overall quality of clinical trial oversight.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.