Protection of Subjects in Large-scale Clinical Trials of Traditional Chinese Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

REN Ming ¹ , LIU Weiwei ² , KANG Liyuan ¹ , ZHANG Junhua ¹ , CAO Hongbo ¹ , WANG Hui ¹ ,  SHANG Hongcai ¹

1. Tianjin Modern Chinese Medicine Key Laboratory – Province and Ministry Co-established State Key Laboratory Cultivation Base, Tianjin University of Traditional Chinese Medicine, Tjianjin 300193, China; 2. The Second Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Large-scale clinical trial; Protection of subject; Traditional Chinese medicine

DOI：

10.7507/1672-2531.20110104

Video：

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With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).

Citation： REN Ming,LIU Weiwei,KANG Liyuan,ZHANG Junhua,CAO Hongbo,WANG Hui,SHANG Hongcai. Protection of Subjects in Large-scale Clinical Trials of Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2011, 11(5): 594-596. doi: 10.7507/1672-2531.20110104 Copy

1.	2 Shang HC, Dai GH, Zhang JH, et al . Myocardial infarction secondary prevention study (MISPS). JGC , 2006, 3(2): 116-119.
2.	3 Shang HC. Baseline characteristics of Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM). Heart , 2010, 96(supplement): A119.
3.	4 Zhang L, Wang Y, Yu L, Liu L, et al . QI-SHEN-YI-QI accelerates angiogenesis after myocardial infarction in rats. Int J Cardiol , 2010, 143(1): 105-109.
4.	5 Xiang YZ, Kang LY, Gao XM, et al . Strategies for antiplatelet targets and agents. Thromb Res , 2008, 123(1): 35-49.
5.	6 Xiang YZ, Xia Y, Gao XM, et al . Platelet activation, and antiplatelet targets and agents: current and novel strategies. Drugs , 2008, 68(12): 1647-1664.
6.	7 Yunfei L, Haibin Q, Yiyu C. Identification of major constituents in the traditional Chinese medicine "QI-SHEN-YI-QI" dropping pill by high-performance liquid chromatography coupled with diode array detection-electrospray ionization tandem mass spectrometry. J Pharm Biomed Anal , 2008, 47(2): 407-412.
7.	商洪才, 张俊华, 戴国华, 等. 中药大规模临床试验及其管理与质量控制. 中西医结合学报, 2007, 5(1): 1-4.
8.	戴国华, 张伯礼, 郭治昕, 等. 大样本多中心临床试验协作单位的选择. 中国临床药理学与治疗学, 2006, 11(6): 717-720.
9.	曹红波, 商洪才, 任明, 等. 中医药大规模随机对照临床试验的病例募集. 中西医结合学报, 2007, 5(3): 243-246.
10.	曹红波, 商洪才, 张伯礼, 等. 大样本、多中心临床试验的监查. 中国新药杂志, 2007, 16(18): 4-6.
11.	张俊华, 戴国华, 商洪才, 等. 中医药大规模临床研究的数据核查. 中国循证医学杂志, 2007, 7(3): 230-232.
12.	戴国华, 张伯礼, 郭治昕, 等. 大样本多中心随机对照试验中的药品管理. 中国循证医学杂志, 2006, 6(8): 609-612.
13.	任明, 商洪才, 张伯礼, 等. 临床试验中不良事件的管理. 中国临床药理学杂志, 2008, 24(5): 452-253, 457.
14.	国家食品药品监督管理局. 药物临床试验质量管理规范. 2003: 第五章, 第十九条.
15.	国家食品药品监督管理局. 药物临床试验质量管理规范. 2003: 第七章, 第四十五条.
16.	戴国华, 张伯礼, 郭治昕, 等. 中心随机化系统在MISPS-TCM项目中的应用. 中国中西医结合杂志, 2007, 27(7): 653-656.

1. 2 Shang HC, Dai GH, Zhang JH, et al . Myocardial infarction secondary prevention study (MISPS). JGC , 2006, 3(2): 116-119.
2. 3 Shang HC. Baseline characteristics of Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM). Heart , 2010, 96(supplement): A119.
3. 4 Zhang L, Wang Y, Yu L, Liu L, et al . QI-SHEN-YI-QI accelerates angiogenesis after myocardial infarction in rats. Int J Cardiol , 2010, 143(1): 105-109.
4. 5 Xiang YZ, Kang LY, Gao XM, et al . Strategies for antiplatelet targets and agents. Thromb Res , 2008, 123(1): 35-49.
5. 6 Xiang YZ, Xia Y, Gao XM, et al . Platelet activation, and antiplatelet targets and agents: current and novel strategies. Drugs , 2008, 68(12): 1647-1664.
6. 7 Yunfei L, Haibin Q, Yiyu C. Identification of major constituents in the traditional Chinese medicine "QI-SHEN-YI-QI" dropping pill by high-performance liquid chromatography coupled with diode array detection-electrospray ionization tandem mass spectrometry. J Pharm Biomed Anal , 2008, 47(2): 407-412.
7. 商洪才, 张俊华, 戴国华, 等. 中药大规模临床试验及其管理与质量控制. 中西医结合学报, 2007, 5(1): 1-4.
8. 戴国华, 张伯礼, 郭治昕, 等. 大样本多中心临床试验协作单位的选择. 中国临床药理学与治疗学, 2006, 11(6): 717-720.
9. 曹红波, 商洪才, 任明, 等. 中医药大规模随机对照临床试验的病例募集. 中西医结合学报, 2007, 5(3): 243-246.
10. 曹红波, 商洪才, 张伯礼, 等. 大样本、多中心临床试验的监查. 中国新药杂志, 2007, 16(18): 4-6.
11. 张俊华, 戴国华, 商洪才, 等. 中医药大规模临床研究的数据核查. 中国循证医学杂志, 2007, 7(3): 230-232.
12. 戴国华, 张伯礼, 郭治昕, 等. 大样本多中心随机对照试验中的药品管理. 中国循证医学杂志, 2006, 6(8): 609-612.
13. 任明, 商洪才, 张伯礼, 等. 临床试验中不良事件的管理. 中国临床药理学杂志, 2008, 24(5): 452-253, 457.
14. 国家食品药品监督管理局. 药物临床试验质量管理规范. 2003: 第五章, 第十九条.
15. 国家食品药品监督管理局. 药物临床试验质量管理规范. 2003: 第七章, 第四十五条.
16. 戴国华, 张伯礼, 郭治昕, 等. 中心随机化系统在MISPS-TCM项目中的应用. 中国中西医结合杂志, 2007, 27(7): 653-656.

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