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 recent years, the Data Monitoring Committee (DMC) has played a crucial role in clinical trials, especially in protecting the safety of subjects and ensuring the integrity and credibility of trial results. With the rise of real-world study, the application of DMC in real-world settings has also gradually attracted attention. In this paper, the application of DMC in real-world study is discussed, the functions of DMC in safety monitoring, efficacy monitoring, research operation quality monitoring, and recommendations for modifications of research designs are analyzed, and the differences in DMC's functions between real-world study and randomized controlled trials are compared. Through case analysis, this paper summarizes the best practices of DMC in real-world study, so as to provide references for future related research.
In the context of increasingly stringent clinical trial quality control, the establishment of Data Monitoring Committee (DMC) 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.
