| 魏立璇,孙 涛,于慧会.126项抗肿瘤药物临床试验方案偏离的分析[J].中国肿瘤,2020,29(7):526-531. |
| 126项抗肿瘤药物临床试验方案偏离的分析 |
| An Analysis on the Protocol Deviation of 126 Anti?鄄tumor Drug Clinical Trials |
| 中文关键词 修订日期：2020-04-29 |
| DOI：10.11735/j.issn.1004-0242.2020.07.A009 |
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| 中文关键词: 抗肿瘤药物 临床试验 方案偏离 |
| 英文关键词:anti-tumor clinical trials protocol deviation |
| 基金项目: |
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| 中文摘要: |
| 摘 要：［目的］ 发现抗肿瘤药物临床试验发生方案偏离的规律和特点，分析发生原因，提出有效措施，为提高试验质量提供一定的参考依据。［方法］ 收集2017—2019年辽宁省肿瘤医院开展的注册类抗肿瘤药物临床试验项目质量自查发现的方案偏离例数、例次、类别，按不同年份、不同科室、国际/国内多中心开展情况进行分组，比较组间方案偏离发生例次的统计学差异，计数资料用百分数表示，组间率的比较采用χ2检验。 ［结果］ 126项抗肿瘤药物临床试验项目中，查阅1247例受试者资料，共437例受试者发生1155例次方案偏离。发生的方案偏离中观察/评价记录不全例次最多（467例次，40.43%），入排问题发生例次最少（12例次，1.04%），不同类型方案偏离发生例次差异有显著统计学意义（P<0.01）。内、外科临床试验发生方案偏离最多的是观察/评价记录不全（内科324例次，37.41%；外科143例次，49.48%）；发生方案偏离例次比率最低在内科是入排问题（7例次，0.81%），在外科是合并用药的使用（4例次，1.38%）；内外科方案偏离发生例次差异有显著统计学意义（P<0.01）。国际/国内多中心方案偏离发生例次比率前两位是观察/评价记录不全和药物使用不当，发生入排问题方案偏离例次比率最低（国际：5例次，0.85%，国内：7例次，1.23%）；两种中心方式方案偏离发生例次差异有显著统计学意义（P<0.01）。［结论］ 抗肿瘤药物临床试验用药周期长，观察指标复杂，易出现观察/评价记录不全、药物使用不当等方案偏离情况，通过项目自查、针对性培训、加强质量控制可以有效避免发生方案偏离，提高抗肿瘤药物临床试验质量。 |
| 英文摘要: |
| Abstract：［Purpose］ To find out the pattern and characteristics of protocol deviation in clinical trials of anti-tumor drugs，to analyze the causes，and to propose possible effective measures to solve the problems，so as to provide scientific references to improve the quality of the trials. ［Methods］Data including the number of deviation projects，cases and deviation categories were collected via self quality assessment of registered anti-tumor drug clinical trial projects from 2017 to 2019 in Liaoning Cancer Hospital，and were grouped in terms of different years，departments and centre approaches(global or domestic multicenters)，and the differences between groups on protocol deviation cases were compared statistically，with count data being expressed in percentage，and rate difference between groups were analyzed by Chi-square test. ［Results］ Among the 126 clinical trials of anti-tumor drugs，the data of 1247 subjects were reviewed，and a total of 437 subjects had 1155 cases of protocol deviation. The number of incomplete observation/evaluation records cases was the largest(467 cases，40.43%)，and the number of inclusion and exclusion cases was the smallest(12 cases，1.04%). There was a statistically significant difference in the number of cases among different categories(P<0.01). In both internal medicine and surgery departments，the rate of incomplete observation/evaluation records was the highest(internal medicine：324 cases，37.41%；surgery： 143 cases，49.48%)；The inclusion and exclusion problem in medicine(7 cases，0.81%) and the combined medication in surgery(4 cases，1.38%) showed the lowest rate of protocol deviation，respectively；There was a statistically significant difference in the number of cases between different departments(P<0.01). The top 2 most frequent categories of cases in global or domestic multicentre protocol deviation were incomplete observation/evaluation records and drug misuse cases；The rate of the inclusion and exclusion problems was lowest(global： 5 cases，0.85%；domestic： 7 cases，1.23%)；There was a statistically significant difference in the number of cases between two approaches of centre(P<0.01).［Conclusion］ Clinical trials of anti-tumor drugs have a long medication cycle with complicated observation indicators，and are prone to have protocol deviations including incomplete observation/evaluation records，drug misuse，et al. Protocol deviations can be effectively avoided by self-inspection，targeted training and quality control，therefore the quality of anti-tumor drug clinical trials. |
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