Drug administration is an extremely important aspect in the design and conduct of randomized controlled trials, which can influence the reliability and quality of the trials’ results. This topic covers issues such as blinding, preparation, packaging, labeling, shipping, dispensing and returning of test articles. Good drug administration procedures should ensure the smooth implementation of large-scale multi-center randomized controlled trials and increase their reliability and usefulness.
Citation：
DAI Guohua,ZHANG Boli,GUO Zhixi,SHANG Hongcai,ZHANG Junhua,YAO Chen,WEN Tiancai,ZHAO Min,ZHANG Junping. Drug Administration in Large-scale Randomized Controlled Multi-center Clinical Trials. Chinese Journal of Evidence-Based Medicine, 2006, 06(8): 609-612. doi:
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Wang JL. Evidence Based Medicine. Beijing:People´s Medical Publishing House; 2003. 74-83.
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孙瑞元，李玉红，王雪融. 新药临床研究的盲法设计问题.中国新药杂志，1999; 8 (9): 634-636.
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王家良，主编. 循证医学. 北京：人民卫生出版社. 2003.74～83.
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Sun RY, Li YH, Wang XR. Blind Design of New Drug Clinical Trial.Chinese Journal of New Drugs, 1999; 8(9): 634-636.
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- 1. Wang JL. Evidence Based Medicine. Beijing:People´s Medical Publishing House; 2003. 74-83.
- 2. 孙瑞元，李玉红，王雪融. 新药临床研究的盲法设计问题.中国新药杂志，1999; 8 (9): 634-636.
- 3. 国家食品药品监督管理局. 药物临床试验质量管理规范. 中国新药与临床杂志，2004; 23 (1): 1-5.
- 4. 王家良，主编. 循证医学. 北京：人民卫生出版社. 2003.74～83.
- 5. Sun RY, Li YH, Wang XR. Blind Design of New Drug Clinical Trial.Chinese Journal of New Drugs, 1999; 8(9): 634-636.
- 6. State Food and Drug Administration. Good Clinical Practice. Chinese Journal of New Drugs and Clinical Remedies, 2004; 23(1):1-5.
