| 改善病情抗风湿治疗药物临床试验质量控制体会 |
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| 引用本文： | 王晓霞,王 洪,刘 燕,白 洁.改善病情抗风湿治疗药物临床试验质量控制体会[J].金属学报,2020,25(1):117-120. |
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| 作者姓名： | 王晓霞 王 洪 刘 燕 白 洁 |
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| 作者单位： | 山西医科大学第二医院，太原 030000，山西 |
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| 基金项目： | 山西省软科学研究（2017041038-4） |
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| 摘 要： | 近年来，许多新的改善病情抗风湿治疗药物（DMARDs）不断涌现，主要集中在生物制剂 DMARDs（bDMARDs）和靶向合成 DMARDs（tsDMARDs）方面。随着临床试验数量的不断增多，加强该类药物临床试验的质量控制具有重要意义。本文着重分析 b/tsDMARDs 药物临床试验实际操作过程中，研究者应关注的重点及难点，以及该类药物临床试验的质量控制要点，并提出解决方法，以期对提高此类临床试验项目的质量提供帮助。
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| 关 键 词： | 改善病情抗风湿药 临床试验 研究者 质量控制 |
| 收稿时间： | 2019-06-05 |
| 修稿时间： | 2020-01-07 |
Experience in quality control of clinical trials of DMARDs |
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| WANG Xiaoxia,WANG Hong,LIU Yan,BAI Jie.Experience in quality control of clinical trials of DMARDs[J].Acta Metallurgica Sinica,2020,25(1):117-120. |
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| Authors: | WANG Xiaoxia WANG Hong LIU Yan BAI Jie |
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| Affiliation: | The Second Hospital of Shanxi Medical University, Taiyuan 030000, Shanxi, China |
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| Abstract: | In recent years, many new DMARDs have been emerging, mainly in bDMARDs and tsDMARDs. With the increasing number of clinical trials, it is of great significance to strengthen the quality control of clinical trials. This paper analyzes the key points and difficulties in practice that the investigator should pay attention to in the b/tsDMARDs clinical trials, as well as the quality control concerns of the clinical trials of such drugs. Some methods are put forward to solve questions above in order to help improve the quality of such clinical trials. |
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| Keywords: | DMARDs clinical trial investigator quality control |
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