| 宦静,杜宏宇,刘毅.FDA警告信中关于研究者总体职责缺陷项的分析[J].中国药事,2019,33(6):705-709 |
| FDA警告信中关于研究者总体职责缺陷项的分析 |
| Analysis of the Deficiency Item “General Responsibilities of Investigators” in FDA Warning Letters |
| 投稿时间：2019-03-16 |
| DOI：10.16153/j.1002-7777.2019.06.015 |
| 中文关键词: FDA 警告信 临床试验 研究者总体职责 缺陷项 |
| 英文关键词: FDA warning letters clinical trial general responsibilities of investigators deficiency item |
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| 中文摘要: |
| 目的：分析FDA警告信中研究者总体职责缺陷项的问题，为加强中国临床试验研究者充分履行其职责提出科学建议。方法：收集FDA警告信中关于“研究者总体职责”缺陷项的具体问题，进一步汇总和分析。结果：共检索2013-2017年发给研究者警告信38封，其中35封涉及缺陷项“研究者总体职责”，具体问题归纳为14类。发生频次从高到低分别是违反入组或排除标准、未按方案给予药物或器械、漏做检查或评估、违反筛选流程、未按时报告不良事件或严重不良事件、主要研究者不尽责或不合理授权等。有4位研究者针对警告信回复采取措施，该措施被FDA认可，故有4项被终止。结论：FDA警告信中关于“研究者总体职责”缺陷项的问题，对我国临床试验的实施起到警示作用。建议药品监管部门加强信息透明度完善奖惩制度、加强培训提高研究者意识、授权合格的研究者并加强监督，从而进一步提高我国临床试验整体质量。 |
| 英文摘要: |
| Objective:To analyze the issue of the deficiency item "General Responsibilities of Investigators" in FDA warning letters, and to put forward scientific suggestions for strengthening the Chinese investigators' fully fulfilling their responsibilities in clinical trials. Methods:The specific problems of the deficiency item "General Responsibilities of Investigators" in the FDA warning letters were collected, summarized and analyzed. Results:A total of 38 warning letters issued to the researchers from 2013 to 2017 were collected among which 35 warning letters contained the deficiency item "General Responsibilities of Investigators", and the specific problems could be classified into 14 types. The frequency of occurrence ranking from high to low were violations of the inclusion or exclusion criteria, failure to administrate drugs or devices according to the protocol, omission of examination or assessment, violation of the screening process, failure to report adverse events or serious adverse events on time, and irresponsibilities of the principle investigators or unreasonable authorization. Four investigators responded to the warning letters and the actions they took were accepted by the FDA, so four warning letters were terminated. Conclusion:The deficiency item "General Responsibilities of Investigators" in FDA warning letters has a warning effect on the implementation of clinical trials in China. It is suggested that the drug regulatory authorities should strengthen information transparency, improve reward and punishment system, strengthen training to enhance the awareness of investigators, authorize qualified investigators and strengthen supervision so as to further improve the overall quality of clinical trials in China. |
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