From concept to practice: evolution and implementation of data monitoring committees in traditional Chinese medicine clinical research

Abstract

Establishing a Data Monitoring Committee (DMC) is crucial for safeguarding participant safety and ensuring data integrity in clinical research. Originating in the United States and subsequently adopted worldwide, the DMC concept has been progressively integrated into China’s clinical research system. Through a series of clinical studies and the introduction of regulations tailored to traditional Chinese medicine (TCM) research, the Chinese Medicine Data Monitoring Committee (CMDMC) framework has been progressively defined, encompassing its formation, operational mechanisms, responsibilities, and standard operating procedures. Nevertheless, as DMC development in China remains at an early stage, CMDMCs continue to face numerous pressing challenges. This article provides an in-depth analysis of the evolution of CMDMCs and the current issues surrounding their implementation within the context of TCM clinical research in China. Further advancement and optimization of CMDMCs will require coordinated efforts among sponsors, committee members, regulatory agencies, and other relevant stakeholders.

Keywords

Data Monitoring Committee / Chinese Medicine Data Monitoring Committee / clinical research / traditional Chinese medicine

References

[1] National Medical Products Administration. Public consultation by the general affairs department of the National Medical Products Administration on the good clinical practice for drugs (draft revision for comment). https://www.gov.cn/zhengce/zhengceku/2020-04/28/content_5507145.htm. Issued April 23, 2020. Accessed November 15, 2025.

[2] Thatte U, Kulkarni-Munshi R.Data safety monitoring boards. Natl Med J India. 2007; 20(4):165-168.

[3] Heart Special Project Committee. Organization, review, and administration of cooperative studies (greenberg report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. Control Clin Trials. 1988; 9(2):137-148.

[4] European Medicines Agency (EMA). Guideline on data monitoring committees. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf. Issued July 27, 2005. Accessed November 15, 2025. 2005. Accessed November 15, 2025.

[5] European Medicines Agency (EMA). Questions and answers on data monitoring committees issues. https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-data-monitoring-committees-issues_en.pdf. Issued September 7, 2020. Accessed November 15, 2025.

[6] Food and Drug Administration. Establishment and operation of clinical trial data monitoring committees. https://www.fda.gov/media/75398/download. Issued March 28, 2006. Accessed November 15, 2025.

[7] Food and Drug Administration. Use of data monitoring committees in clinical trials. https://www.fda.gov/media/176107/download. Issued February 13, 2024. Accessed November 15, 2025.

[8] Pharmaceuticals and Medical Devices Agency. Guideline on data monitoring committee. https://www.pmda.go.jp/files/000232300.pdf. Issued April 4, 2013. Accessed November 15, 2025.

[9] Xu P, Xu L, Yang RN, Li W, Chen KX. Analysis of research and development trends of new drugs. Bull Chin Acad Sci. 2024; 39(5):821-831.

[10] National Medical Products Administration. General principles for clinical research of new traditional Chinese medicines (2015). https://mobi.catcm.org.cn/129/201511/1012.html. Issued November 13, 2015. Accessed November 15, 2025.

[11] National Medical Products Administration. Guidelines for biostatistics in drug clinical trials. https://law.pharmnet.com.cn/laws/detail_3579.html. Issued June 1st, 2016. Accessed November 15, 2025.

[12] National Medical Products Administration. Guideline for data monitoring committee of drug clinical trials (trial implementation). https://www.cnpharm.com/c/2020-09-23/756774.shtml. Issued September 21, 2020. Accessed November 15, 2025.

[13] Yang Y, Li X, Chen G, et al. Traditional Chinese medicine compound (Tongxinluo) and clinical outcomes of patients with acute myocardial infarction: the CTS-AMI randomized clinical trial. JAMA. 2023; 330(16):1534-1545.

[14] Cheang I, Yao W, Zhou Y, et al. The traditional Chinese medicine Qiliqiangxin in heart failure with reduced ejection fraction: a randomized, double-blind, placebo-controlled trial. Nat Med. 2024; 30(8):2295-2302.

[15] Ji H, Zhao X, Chen X, et al. Jinlida for diabetes prevention in impaired glucose tolerance and multiple metabolic abnormalities: the FOCUS randomized clinical trial. JAMA Intern Med. 2024; 184(7):727-735.

[16] Zou X, Chang K, Fan G, et al. Effectiveness and safety of Sanhan Huashi granules versus nirmatrelvir-ritonavir in adult patients with COVID-19: a randomized, open-label, multicenter trial. Sci Bull. 2024; 69(12):1954-1963.

[17] Huang J, Shi J, Fu J, et al. Pharmacological effects and mechanism of Maxing Shigan decoction in the treatment of influenza a viral pneumonia. J Ethnopharmacol. 2025; 353:120275.

[18] Yu Y, Hu S, Li G, et al. Comparative effectiveness of Di’ao Xin Xue Kang capsule and Compound Danshen tablet in patients with symptomatic chronic stable angina. Sci Rep. 2014; 4:7058.

[19] Liu J, Li DD, Dong W, et al. Detection of an anti-angina therapeutic module in the effective population treated by a multi-target drug Danhong injection: a randomized trial. Signal Transduct Target Ther. 2021; 6(1):329.

[20] Leng YY, Yu YY, Shen CT, et al. The practice of the Chinese medicine data monitoring committee in the “phase IV clinical trial of Danhong injection for treating stable coronary atherosclerotic heart disease”. World Clin Drug. 2025; 46(4):340-347.

[21] Yu YN, Liu J, Wang Z. Post-marketing effectiveness evaluation of traditional Chinese medicine in paradigm based on “proving efficacy, conforming standard, and exploring mechanism”: a case study of Danhong injection. China J Chin Mater Med. 2023; 48(1):279-284.

[22] Standard operating procedures for Chinese medicine data monitoring committees of clinical studies. China Association of Chinese Medicine Web site. https://www.doc88.com/p-20659531830994.html. Issued September 12, 2019. Accessed November 15, 2025.

[23] Sun B, Zhang JC, Li G. Current status and analysis of clinical investigators supervision in clinical trials. Chin J New Drugs Clin Rem. 2023; 42(9):571-576.

[24] Wang Z, Shen CT. Practice and Case Analysis of Clinical Data Monitoring Committees in Traditional Chinese Medicine. Beijing, China: China Press of Traditional Chinese Medicine; 2024.

[25] Yu Y, Tang L, Cui F, et al. Effect of Qizhitongluo capsule on lower limb rehabilitation after stroke: a randomized clinical trial. Pharmacol Res. 2021; 165:105464.

[26] Liu J, Wang N, Dang HX, et al. Standard operating procedures for Chinese medicine data monitoring committees of clinical studies. Chin J Integr Med. 2021; 27(7):483-489.

[27] Zheng Y, Li P, Liu J, Wang Z, Dang H, Yu Y. Analysis of the application of the clinical trial data monitoring committee in the research and development of new oncology drugs in China. World Clin Drug. 2025; 46(4):315-322.

[28] Chen Y, Zheng Y, Li P, Liu J, Yu Y, Wang Z. Analysis of data monitoring committee applications in cardiovascular drug development in China. World Clin Drug. 2025; 46(4):323-331.

[29] Li P, Zheng Y, Liu J, Wang Z, Yu Y, Dang H. Application analysis of clinical trial data monitoring committee in the new pediatric drug research and development in China. World Clin Drug. 2025; 46(4):332-339.

[30] Hinder M, Madesh N, Hartl D, Schuhmacher A. The role of data monitoring committees in drug research. Drug Discov Today. 2025; 30(10):104474.

[31] 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.

[32] Fleming TR, DeMets DL, Roe MT, et al. Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials. 2017; 14(2):115-123.

[33] Gheorghiade M, Böhm M, Greene SJ, et al. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013; 309(11):1125-1135.

[34] Zhang S, Wang W, Pi X, He Z, Liu H. Advances in the application of traditional Chinese medicine using artificial intelligence: a review. Am J Chin Med. 2023; 51(5):1067-1083.