Current status and considerations of Data Monitoring Committee (DMC) reports in clinical trials introduction_Chinese Journal of Evidence-Based Medicine

Authors：

ZHENG Yu ¹ , LIU Jun ¹ , WANG Zhong ¹ ,  DANG Haixia ² , YU Yanan ¹

1. Institute of Clinical Basic Medicine of Traditional Chinese Medical Sciences, Beijing 100700, P. R. China;
2. Research Center for the Development of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding author：

DANG Haixia, Email: danghaixia@126.com

Keywords：

Data Monitoring Committee; Interim analysis; DMC report

DOI：

10.7507/1672-2531.202502101

Video：

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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.

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2.	国家药品监督管理局药品审评中心. 《药物临床试验数据监查委员会指导原则(试行)》通告 (2020年第27号). 2020.
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14.	O’Connell M, Pietzko K. Interactive clinical data review for safety assessment and trial operations management. Berlin: PhUSE 2010 conference proceedings, 2010.
15.	Calis KA, Archdeacon P, Bain R, et al. Recommendations for Data Monitoring Committees from the clinical trials transformation initiative. Clin Trials, 2017, 14(4): 342-348.
16.	Grant AM, Altman DG, Babiker AB, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess, 2005, 9(7): 1-238.
17.	Neaton JD, Grund B, Wentworth D. How to construct an optimal interim report: what the data monitoring committee does and doesn't need to know. Clin Trials, 2018, 15(4): 359-365.
18.	DeMets DL, Wittes J. Data monitoring committee interim reports: we must get there soon! Clin Trials, 2022, 19(1): 107-111.
19.	Vandemeulebroecke M, Baillie M, Mirshani A, et al. DMC reports in the 21st century: towards better tools for decision-making. Trials, 2023, 24(1): 289.
20.	Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in clinical trials: a practical perspective. New Jersey: John Wiley & Sons Ltd, 2019.
21.	中华中医药学会. 中医药临床研究数据监查技术规》. 2019.
22.	Wittes J. The Independent Statistical Reporting Group: guiding principles and best practices. 2024.
23.	Matsubara N, de Wit R, Balar AV, et al. Pembrolizumab with or without lenvatinib as first-line therapy for patients with advanced urothelial carcinoma (LEAP-011): a phase 3, randomized, double-blind trial. Eur Urol, 2024, 85(3): 229-238.
24.	CDISC. CDISC Pilot replication repository. 2019.
25.	Harrell F. Example closed meeting Data Monitoring Committee report. 2007.
26.	Fleming TR, Wittes J, Fiuzat M, et al. Training the next generation of Data Monitoring Committee members: an initiative of the heart failure collaboratory. JACC Heart Fail, 2024, 12(8): 1317-1327.
27.	Rockhold F, Mahaffey K, DeMets D. Training new DMC members: a call to action. Ther Innov Regul Sci, 2024, 58(2): 234-235.

1. FDA. Guidance for clinical trial sponsors establishment and operation of Clinical Trial Data Monitoring Committees. 2006.
2. 国家药品监督管理局药品审评中心. 《药物临床试验数据监查委员会指导原则(试行)》通告 (2020年第27号). 2020.
3. 黄举凯, 张力, 王忠, 等. 临床研究数据与安全监查国际发展现状与思考. 药物评价研究, 2019, 42(1): 10-17.
4. Ellenberg SS, Fleming TR, DeMets DL. Responsibilities of the Data Monitoring Committee and motivating illustrations. Data Monitoring Committees in clinical trials. 2nd ed. New Jersey: John Wiley & Son Ltd, 2019.
5. Wittes J. Behind closed doors: the data monitoring board in randomized clinical trials. Stat Med, 1993, 12(5-6): 419-424.
6. FDA. Use of Data Monitoring Committees in clinical trials guidance for industry. 2024.
7. Lewis RJ, Calis KA, DeMets DL. Enhancing the scientific integrity and safety of clinical trials: recommendations for Data Monitoring Committees. JAMA, 2016, 316(22): 2359-2360.
8. Fisher M, Roecker EB, DeMets D. The role of an independent statistical analysis center in the industrymodified National Institutes of Health model. Drug Inf J, 2001, 35: 115-129.
9. Wittes J, Schactman M. On independent data monitoring committees in oncology clinical trials. Chin Clin Oncol, 2014, 3(3): 40.
10. Zeng L, Hamasaki T, Evans SR. Data Monitoring Committee reports: telling the data's story. Ther Innov Regul Sci, 2025, 59(2): 222-233.
11. Wang W, Revis R, Nilsson M, et al. Clinical trial drug safety assessment with interactive visual analytics. Stat Biopharm Res, 2021, 13(3): 355-66.
12. Wildfire J, Bailey R, Krouse RZ, et al. The Safety Explorer Suite: interactive safety monitoring for clinical trials. Ther Innov Regul Sci, 2018, 52(6): 696-700.
13. Evans SR, Zeng L, Dai W. The Data and Safety Monitoring Board: the toughest job in clinical trials. NEJM Evid, 2023, 2(2): EVIDctw2200220.
14. O’Connell M, Pietzko K. Interactive clinical data review for safety assessment and trial operations management. Berlin: PhUSE 2010 conference proceedings, 2010.
15. Calis KA, Archdeacon P, Bain R, et al. Recommendations for Data Monitoring Committees from the clinical trials transformation initiative. Clin Trials, 2017, 14(4): 342-348.
16. Grant AM, Altman DG, Babiker AB, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess, 2005, 9(7): 1-238.
17. Neaton JD, Grund B, Wentworth D. How to construct an optimal interim report: what the data monitoring committee does and doesn't need to know. Clin Trials, 2018, 15(4): 359-365.
18. DeMets DL, Wittes J. Data monitoring committee interim reports: we must get there soon! Clin Trials, 2022, 19(1): 107-111.
19. Vandemeulebroecke M, Baillie M, Mirshani A, et al. DMC reports in the 21st century: towards better tools for decision-making. Trials, 2023, 24(1): 289.
20. Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in clinical trials: a practical perspective. New Jersey: John Wiley & Sons Ltd, 2019.
21. 中华中医药学会. 中医药临床研究数据监查技术规》. 2019.
22. Wittes J. The Independent Statistical Reporting Group: guiding principles and best practices. 2024.
23. Matsubara N, de Wit R, Balar AV, et al. Pembrolizumab with or without lenvatinib as first-line therapy for patients with advanced urothelial carcinoma (LEAP-011): a phase 3, randomized, double-blind trial. Eur Urol, 2024, 85(3): 229-238.
24. CDISC. CDISC Pilot replication repository. 2019.
25. Harrell F. Example closed meeting Data Monitoring Committee report. 2007.
26. Fleming TR, Wittes J, Fiuzat M, et al. Training the next generation of Data Monitoring Committee members: an initiative of the heart failure collaboratory. JACC Heart Fail, 2024, 12(8): 1317-1327.
27. Rockhold F, Mahaffey K, DeMets D. Training new DMC members: a call to action. Ther Innov Regul Sci, 2024, 58(2): 234-235.

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