The application of Data Monitoring Committee (DMC) in real-world study_Chinese Journal of Evidence-Based Medicine

Authors：

ZHENG Hao 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; YU Yanan, Email: yyn433@sina.com

Keywords：

Data Monitoring Committee (DMC); Real-world study; Safety monitoring; Efficacy monitoring; Research quality monitoring

DOI：

10.7507/1672-2531.202508107

Video：

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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.

1.	FDA. Use of Data Monitoring Committees in clinical trials guidance for industry. 2024.
2.	國家藥品監督管理局藥品審評中心. 國家藥監局藥審中心關于發布《藥物臨床試驗數據監查委員會指導原則(試行)》的通告(2020年第27號). 2020.
3.	李艷蓉, 王海學. 數據監查委員會在新型冠狀病毒肺炎疫情臨床試驗監管的應用和挑戰. 中國臨床藥理學雜志, 2020, 36(13): 1903-1907.
4.	FDA. Guidance for clinical trial sponsors establishment and operation of Clinical Trial Data Monitoring Committees. 2006.
5.	陳亞飛, 鄭宇, 李鵬博, 等. 臨床試驗數據監查委員會在我國心血管領域新藥研發中的應用分析. 世界臨床藥物, 2025, 46(4): 323-331.
6.	李鵬博, 鄭宇, 劉駿, 等. 臨床試驗數據監查委員會在我國兒科新藥研發中的應用分析. 世界臨床藥物, 2025, 46(4): 332-339.
7.	胡斌, 馬巧琳, 楊帆, 等. 基于真實世界研究方法的醫學研究進展. 中醫臨床研究, 2022, 14(22): 141-145.
8.	楊松, 馬龍騰, 張菁菁. 中國臨床醫學真實世界研究施行規范. 解放軍醫學雜志, 2018, 43(1): 1-6.
9.	Bunning BJ, Hedlin H, Chen JH, et al. The evolving role of data & safety monitoring boards for real-world clinical trials. J Clin Transl Sci, 2023, 7(1): e179.
10.	Major-Pedersen A, McCullen MK, Sabol ME, et al. A joint industry-sponsored Data Monitoring Committee model for observational, retrospective drug safety studies in the real-world setting. Pharmacoepidemiol Drug Saf, 2021, 30(1): 9-16.
11.	Center for Drug Evaluation, National Medical Products Administration. Guideline on clinical trial data monitoring committees (Draft for public review). Beijing: NMPA, 2019.
12.	王蕾, 劉駿, 黨海霞, 等. 丹紅注射液Ⅳ期臨床試驗的數據與安全監察. 中國藥學雜志, 2015, 50(4): 375-378.
13.	楊忠奇, 唐雅琴, 湯慧敏, 等. 基于人用經驗的中藥新藥安全性評價. 中國中藥雜志, 2025, 50(3): 812-816.
14.	Sandercock PA, Counsell C, Kane EJ. Anticoagulants for acute ischaemic stroke. Cochrane Database Syst Rev, 2015, (3): CD000024.
15.	Prasad K, Siemieniuk R, Hao Q, et al. Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline. BMJ, 2018, 363: k5130.
16.	Nolte CH, von Rennenberg R, Litmeier S, et al. Prediction of acute coronary syndrome in acute ischemic stroke (PRAISE) - protocol of a prospective, multicenter trial with central reading and predefined endpoints. BMC Neurol, 2020, 20(1): 318.
17.	Cook D, Sinuff T, Zytaruk N, et al. Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis. J Crit Care, 2009, 24(2): 168-175.
18.	Van Norman GA. Data safety and monitoring boards should be required for both early- and late-phase clinical trials. JACC Basic Transl Sci, 2021, 6(11): 887-896.
19.	曹麗亞, 謝林利, 謝江川, 等. 我國臨床試驗中建立獨立數據監查委員會的分析與探討. 藥物流行病學雜志, 2023, 32(1): 89-94.
20.	Harrington D, Drazen JM. Learning from a trial stopped by a Data and Safety Monitoring Board. N Engl J Med, 2018, 378(21): 2031-2032.
21.	盛松, 黃燁. 基于真實世界開展中醫藥研究的優勢和局限性. 中西醫結合心腦血管病雜志, 2023, 21(2): 377-379.
22.	Stürmer T, Wang T, Golightly YM, et al. Methodological considerations when analysing and interpreting real-world data. Rheumatology (Oxford), 2020, 59(1): 14-25.
23.	國家藥品監督管理局醫療器械技術審評中心. 國家藥監局器審中心關于發布醫療器械真實世界研究設計和統計分析注冊審查指導原則的通告(2024年第3號). 2024.
24.	瞿俊晨, 盧吟秋, 殷秋憶, 等. 呋喹替尼治療晚期惡性腫瘤的臨床療效與安全性真實世界研究. 中國藥物應用與監測, 2025, 22(2): 333-337.
25.	申春悌, 王忠. 中醫藥臨床研究數據監查委員會實踐與案例解析. 北京: 中國中醫藥出版社, 2024.
26.	Huang Z, Rockhold FW, Jones WS, et al. The challenges of data safety monitoring for a pragmatic study: lessons from the ADAPTABLE study. Contemp Clin Trials, 2022, 115: 106732.
27.	Ellenberg SS, Culbertson R, Gillen DL, et al. Data monitoring committees for pragmatic clinical trials. Clin Trials, 2015, 12(5): 530-536.
28.	Gurung R, Gurung A, Basnet O, et al. REFINE (Rapid Feedback for quality Improvement in Neonatal rEsuscitation): an observational study of neonatal resuscitation training and practice in a tertiary hospital in Nepal. BMC Pregnancy Childbirth, 2020, 20(1): 756.
29.	宋觀禮, 張潤順, 劉保延, 等. 真實世界中醫臨床診療信息數據化實施與質量控制. 中醫雜志, 2015, 56(3): 198-201.
30.	Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in clinical trials: a practical perspective. 2019.
31.	中華中醫藥學會. 中醫藥臨床研究數據監查技術規范: T/CACM 1323-2019. 北京: 中華中醫藥學會, 2019.
32.	Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the Joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Value Health, 2017, 20(8): 1003-1008.

1. FDA. Use of Data Monitoring Committees in clinical trials guidance for industry. 2024.
2. 國家藥品監督管理局藥品審評中心. 國家藥監局藥審中心關于發布《藥物臨床試驗數據監查委員會指導原則(試行)》的通告(2020年第27號). 2020.
3. 李艷蓉, 王海學. 數據監查委員會在新型冠狀病毒肺炎疫情臨床試驗監管的應用和挑戰. 中國臨床藥理學雜志, 2020, 36(13): 1903-1907.
4. FDA. Guidance for clinical trial sponsors establishment and operation of Clinical Trial Data Monitoring Committees. 2006.
5. 陳亞飛, 鄭宇, 李鵬博, 等. 臨床試驗數據監查委員會在我國心血管領域新藥研發中的應用分析. 世界臨床藥物, 2025, 46(4): 323-331.
6. 李鵬博, 鄭宇, 劉駿, 等. 臨床試驗數據監查委員會在我國兒科新藥研發中的應用分析. 世界臨床藥物, 2025, 46(4): 332-339.
7. 胡斌, 馬巧琳, 楊帆, 等. 基于真實世界研究方法的醫學研究進展. 中醫臨床研究, 2022, 14(22): 141-145.
8. 楊松, 馬龍騰, 張菁菁. 中國臨床醫學真實世界研究施行規范. 解放軍醫學雜志, 2018, 43(1): 1-6.
9. Bunning BJ, Hedlin H, Chen JH, et al. The evolving role of data & safety monitoring boards for real-world clinical trials. J Clin Transl Sci, 2023, 7(1): e179.
10. Major-Pedersen A, McCullen MK, Sabol ME, et al. A joint industry-sponsored Data Monitoring Committee model for observational, retrospective drug safety studies in the real-world setting. Pharmacoepidemiol Drug Saf, 2021, 30(1): 9-16.
11. Center for Drug Evaluation, National Medical Products Administration. Guideline on clinical trial data monitoring committees (Draft for public review). Beijing: NMPA, 2019.
12. 王蕾, 劉駿, 黨海霞, 等. 丹紅注射液Ⅳ期臨床試驗的數據與安全監察. 中國藥學雜志, 2015, 50(4): 375-378.
13. 楊忠奇, 唐雅琴, 湯慧敏, 等. 基于人用經驗的中藥新藥安全性評價. 中國中藥雜志, 2025, 50(3): 812-816.
14. Sandercock PA, Counsell C, Kane EJ. Anticoagulants for acute ischaemic stroke. Cochrane Database Syst Rev, 2015, (3): CD000024.
15. Prasad K, Siemieniuk R, Hao Q, et al. Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline. BMJ, 2018, 363: k5130.
16. Nolte CH, von Rennenberg R, Litmeier S, et al. Prediction of acute coronary syndrome in acute ischemic stroke (PRAISE) - protocol of a prospective, multicenter trial with central reading and predefined endpoints. BMC Neurol, 2020, 20(1): 318.
17. Cook D, Sinuff T, Zytaruk N, et al. Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis. J Crit Care, 2009, 24(2): 168-175.
18. Van Norman GA. Data safety and monitoring boards should be required for both early- and late-phase clinical trials. JACC Basic Transl Sci, 2021, 6(11): 887-896.
19. 曹麗亞, 謝林利, 謝江川, 等. 我國臨床試驗中建立獨立數據監查委員會的分析與探討. 藥物流行病學雜志, 2023, 32(1): 89-94.
20. Harrington D, Drazen JM. Learning from a trial stopped by a Data and Safety Monitoring Board. N Engl J Med, 2018, 378(21): 2031-2032.
21. 盛松, 黃燁. 基于真實世界開展中醫藥研究的優勢和局限性. 中西醫結合心腦血管病雜志, 2023, 21(2): 377-379.
22. Stürmer T, Wang T, Golightly YM, et al. Methodological considerations when analysing and interpreting real-world data. Rheumatology (Oxford), 2020, 59(1): 14-25.
23. 國家藥品監督管理局醫療器械技術審評中心. 國家藥監局器審中心關于發布醫療器械真實世界研究設計和統計分析注冊審查指導原則的通告(2024年第3號). 2024.
24. 瞿俊晨, 盧吟秋, 殷秋憶, 等. 呋喹替尼治療晚期惡性腫瘤的臨床療效與安全性真實世界研究. 中國藥物應用與監測, 2025, 22(2): 333-337.
25. 申春悌, 王忠. 中醫藥臨床研究數據監查委員會實踐與案例解析. 北京: 中國中醫藥出版社, 2024.
26. Huang Z, Rockhold FW, Jones WS, et al. The challenges of data safety monitoring for a pragmatic study: lessons from the ADAPTABLE study. Contemp Clin Trials, 2022, 115: 106732.
27. Ellenberg SS, Culbertson R, Gillen DL, et al. Data monitoring committees for pragmatic clinical trials. Clin Trials, 2015, 12(5): 530-536.
28. Gurung R, Gurung A, Basnet O, et al. REFINE (Rapid Feedback for quality Improvement in Neonatal rEsuscitation): an observational study of neonatal resuscitation training and practice in a tertiary hospital in Nepal. BMC Pregnancy Childbirth, 2020, 20(1): 756.
29. 宋觀禮, 張潤順, 劉保延, 等. 真實世界中醫臨床診療信息數據化實施與質量控制. 中醫雜志, 2015, 56(3): 198-201.
30. Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in clinical trials: a practical perspective. 2019.
31. 中華中醫藥學會. 中醫藥臨床研究數據監查技術規范: T/CACM 1323-2019. 北京: 中華中醫藥學會, 2019.
32. Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the Joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Value Health, 2017, 20(8): 1003-1008.

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