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| Selecting strategy for test unit in re-clinical research of post-marketing drug |
| Hits 1711 Download times 1826 Received:April 18, 2013 |
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| DOI
10.11656/j.issn.1672-1519.2013.10.04 |
| Key Words
unit selection;research for post-marketing drug;clinical trial |
| Author Name | Affiliation | | CAO Hong-bo | Institute of Traditional Chinese Medicine, Tianjin University of TCM, Tianjin 300193, China
Tianjin Institute of Clinical Evaluation, Tianjin 300193, China | | SHANG Hong-cai | Institute of Traditional Chinese Medicine, Tianjin University of TCM, Tianjin 300193, China
Tianjin Institute of Clinical Evaluation, Tianjin 300193, China |
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| Abstract
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| The selection of study unit is an important thing for the quality control in clinical trials of post-marketing drug. Improper selection for the trial unit will result in various risks for the clinical investigation, including unbalanced distribution of these units;poor management of the drugs;recruitment number does not meet the standard;the enrolled units must be regulated;the staffs working in the unit must be regulated, varied economic requirement of the trial staffs as well as the medical disputes, etc.. In this paper, we pursued this issue by learning the experiences of international clinical trial management of post-marketing drugs, and discussed improvements that can be made in the conduct of clinical trials in China, hopping of providing some methodological guidance for future researches. |
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