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.
The Institute for Clinical and Economic Review (ICER) has long been committed to promoting fair pricing and equitable access in U.S. healthcare, and has developed a value assessment framework to guide this work. ICER’s value assessment framework was first conceived in 2015 and subsequently updated in 2017 and 2020. This study introduces the ICER value assessment framework (2023). It focuses on elucidating the major revisions within three key areas: cost-effectiveness analysis, health technology assessment (HTA) methods related to health equity and patient engagement, and discusses these changes in light of their central methodological implications. The aim is to provide informative insights and methodological references that may be of value for the development and refinement of HTA practices in China.
