| 陈红芳,窦文琴,丁绍红,等.药物临床试验质量控制中发现的问题及改进措施探讨[J].安徽医药,2020,24(3):613-616. |
| 药物临床试验质量控制中发现的问题及改进措施探讨 |
| Probe into problems and improvement measures in quality control of drug clinical trials |
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| DOI：10.3969/j.issn.1009?6469.2020.03.049 |
| 中文关键词: 临床试验 药物评价 知情同意 质量控制 药物毒性 药物警戒性 |
| 英文关键词: Clinical trial Drug evaluation Informed consent Quality control Drug toxicity Pharmacovigilance |
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| 中文摘要: |
| 目的探讨药物临床试验质量控制中发现的问题及改进措施。方法采用回顾性分析方法，对江阴市人民医院在 2010年 1月至 2018年 12月开展的 Ⅱ~Ⅳ期 59项药物临床试验质控中发现的问题进行分析。为此采取了加强临床试验人员培训，完善质控体系，建立考核制度等措施。结果通过质控发现药物临床试验在实施中，执行知情同意，入选和排除标准，病例报告表记录，合并用药，药品管理，生物样本管理，严重不良事件、不良事件报告，异常值随访等方面仍需进一步持续改进。随着逐年一系列改进措施的落实， 2010—2018年逐年出现质控问题总例次分别为 76、59、51、38、32、28、26、11、4，从 2017年开始大幅度下降。结论通过加强质控充分保护受试者权益，保证临床试验数据真实、科学、可靠。 |
| 英文摘要: |
| Objective To discuss the problems found in the quality control of drug clinical trials and the improvement measures to improve the quality of drug clinical trials.Methods Retrospective analysis was used to analyze the problems found in the qualitycontrol of 59 phase II?IV clinical drug studies carried out by the People’s Hospital of Jiangyin from January 2010 to December 2018.To this end，measures had been taken to strengthen the training of clinical trial personnel，improve the quality control system and establish an assessment system.Results Through quality control，it was discovered that during implementation of drug clinical trials，the following aspects needed further improvement:the implementation of informed consent，selection and exclusion criteria， case report form records，combined drug use，drug management，biological sample management，reports of serious adverse events，ad? verse events and follow?up of abnormal values.With the implementation of a series of improvement measures year by year，the num? ber of quality control problems that occurred from 2010 to 2018 was 76，59，51，38，32，28，26，11 and 4，which had declined signifi? cantly from 2017.Conclusion By strengthening quality control，the rights and interests of subjects are fully protected，and the au? thenticity，scientificity and reliability of clinical trial data are ensured. |
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