Standard Operating Procedure for Drug Labeling and Dynamic Medication Management of Double-blinded Randomized Controlled Trial_Chinese Journal of Evidence-Based Medicine

Authors：

 LIGeng ¹ , LIXiao-yan ¹ , XUANMei-ling ¹ ,  WENZe-huai ^1,2

1. The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China;
2. National Center for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China;

Corresponding author：

WENZe-huai, Email: wenzh@gzucm.edu.cn

Keywords：

Dynamic medication management; Drug labeling; Standard operating procedure; Randomized controlled trial

DOI：

10.7507/1672-2531.20150100

Video：

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Abstract Full text Figures/Tables Video References Cited by

Dynamic medication management can help to improve efficacy and save consumption in such trials when an investigational medication is expensive or in short supply or has a fairly short shelf-life in a long-lasting clinical trial, or, if protocol changes during study period. We presented the standard operating procedure of dynamic medication management and drug labeling through an instance of double-blind randomized controlled trial of Chinese Medicine for hepatopathy. Compared to conventional drug labeling, dynamic medication management and drug labeling is more flexibility to deal with problems during the study period, such as protocol update, medication waste, and outdated medication and so on. Appropriate method and reasonable procedure can ensure the precise implementation for drug labeling and medication management of double-blinded randomized controlled trials.

Citation： LIGeng, LIXiao-yan, XUANMei-ling, WENZe-huai. Standard Operating Procedure for Drug Labeling and Dynamic Medication Management of Double-blinded Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2015, 15(5): 607-611. doi: 10.7507/1672-2531.20150100 Copy

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1. Boutron I, Estellat C, Guittet L, et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments:a systematic review. PLoS Med, 2006, 3(10):425.
2. 温泽淮, 王奇, 梁伟雄, 等. 生脉胶囊治疗慢性心衰双盲随机对照试验中盲法的实施. 广州中医药大学学报, 2004, 21(4):315-322.
3. 刘建平. 中医药临床试验的对照与盲法设置. 中国中西医结合杂志, 2003, 3(10):789-791.
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance for Industry E6 Good Clinical Practice:Consolidated Guidance. Available at:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf, 1996:2-3.
5. 闫世艳, 何丽云, 文天才, 等. 双盲临床试验中动态药物编盲方法. 中医杂志, 2013, 54(12):1004-1006.
6. 李雪峰, 吴艳乔. 药物临床试验中的随机化与盲法. 西南军医, 2011, 3(2):326-327.
7. 王国芳, 谢琪, 王晓菲. 双盲双模拟临床试验的药物准备及编盲. 中药新药与临床药理, 2005, 16(4):308-310.
8. 国家食品药品监督管理总局. 药物临床试验质量管理规范. Available at:http://www.sda.gov.cn/WS01/CL0053/24473.html.
9. European Commission enterprise and industry. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 13 Investigational Medicinal Products. Available at:http://www.gmp-compliance.org/guidemgr/files/2009_06_ANNEX13.PDF.
10. McEntegart D. Randomization, Blinding and Drug Supply in Interactive Voice Response Trials. Available at:http://hstalks.com/?t=BL0441311.
11. Peterson M, Byrom B, Dowlman N, et al. Optimizing clinical trial supply requirements:simulation of computer-controlled supply chain management. Clin Trials, 2004, 1(4):399-412.
12. Hamilton S, Kai F. Efficient Drug Supply Algorithms for Stratified Clinical Trials. Available at:http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=84610.
13. Dowlman N, Lang M, McEntegart D, et al. Optimizing the Supply Chain Through Trial Simulation:Simulation tools empower sponsors to confidently choose the best drug supply strategies in IVR Trials. Available at:http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Feature+Article/Optimizing-the-Supply-Chain-Through-Trial-Simulati/ArticleStandard/Article/detail/103362.
14. Byrom B. Using IVRS in Clinical Trial Management. Available at:http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/data/articlestandard//appliedclinicaltrials/392002/32708/article.pdf.

Chinese Journal of Evidence-Based Medicine

Standard Operating Procedure for Drug Labeling and Dynamic Medication Management of Double-blinded Randomized Controlled Trial

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