| 杨敏,程国华.药物临床试验质量影响因素调查分析[J].中国药事,2023,(2):163-170 |
| 药物临床试验质量影响因素调查分析 |
| Survey Analysis on Quality Infl uencing Factors of Drug Clinical Trials |
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| DOI：10.16153/j.1002-7777.2023.02.006 |
| 中文关键词: 药物临床试验 质量 影响因素 调查分析 问卷 |
| 英文关键词: drug clinical trial quality infl uencing factors investigation and analysis questionnaire |
| 基金项目:广东省本科高校教学质量与教学改革工程建设项目(编号82620246)；汕头市科技计划项目(编号 191217115267974) |
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| 中文摘要: |
| 目的：探讨药物临床试验实施过程中质量影响的关键因素。方法：以药物临床试验质量管理规范 (Good Clinical Practice，GCP)培训、方案设计、知情同意书签署、受试者依从性、临床试验记录和报告、试验用药品管理、不良事件(Adverse Events，AE)/严重不良事件(Serious Adverse Events，SAE)上报、项目质控措施和比例等内容为参照制定调查问卷，对药物临床试验相关人员进行调查分析。结果：合计收到191份问卷，其中有效问卷183份，有效率95.8%。临床试验中常见方案设计与医院常规操作相违背 (61.20%)、知情同意书信息填写有误/不规范(34.97%)、访视超窗(38.80%)、试验数据/报告填写/ 修改不规范(55.74%)、试验用药品相关管理记录不完整(36.61%)、AE/SAE漏报(40.44%)等问题， 以及GCP培训、质控力度、研究团队、申办方质量管理体系建设等都是影响药物临床试验质量的关键因素。结论：加强药物临床试验参与各方的培训、提高GCP认知是保障临床试验整体质量的有力措施。 |
| 英文摘要: |
| Objective: To discuss key factors of the quality affecting in the process of drug clinical trial implementation. Methods: The questionnaire was developed with reference to the training of Good Clinical Practice (GCP), designing of protocol, signing of informed consent form, compliance of subjects, records and reports of clinical trials, management of experimental drugs, reports of adverse events (AE)/serious adverse events(SAE), quality control measures and proportion of projects, etc., drug clinical trial related personnel were investigated and analyzed. Results: A total of 191 questionnaires were received, of which 183 were valid, with an eff ective rate of 95.8%. There are some common problems such as contrary protocol design to hospital practice (61.20%), incorrect/non-standard fi lling of informed consent form (34.97%), timeout for the followingup (38.80%), nonstandard fi lling/modifying for test data/reports(55.74%), incomplete records for management of experimental drugs (36.61%), missing report of AE/SAE (40.44%) in clinical trials. GCP training, quality control, research team and the construction of the sponsor's quality management system are all the key aff ecting factors for the quality of drug clinical trials. Conclusion: Strengthening the training of participants in drug clinical trials and improving GCP awareness are eff ective measures to ensure the overall quality of clinical trials. |
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