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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Copyright ? the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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- 1. Wang JL. Evidence Based Medicine. Beijing:People´s Medical Publishing House; 2003. 74-83.
- 2. 孫瑞元，李玉紅，王雪融. 新藥臨床研究的盲法設計問題.中國新藥雜志，1999; 8 (9): 634-636.
- 3. 國家食品藥品監督管理局. 藥物臨床試驗質量管理規范. 中國新藥與臨床雜志，2004; 23 (1): 1-5.
- 4. 王家良，主編. 循證醫學. 北京：人民衛生出版社. 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.
