| 魏立璇,孙 涛,赵 茜.抗肿瘤药物临床试验中观察/评价记录不全方案偏离的影响因素分析[J].中国肿瘤,2020,29(10):792-798. |
| 抗肿瘤药物临床试验中观察/评价记录不全方案偏离的影响因素分析 |
| Analysis of Factors Influencing the Deviation of Incomplete Observation / Evaluation Records in Clinical Trials of Anti-tumor Drugs |
| 中文关键词 修订日期：2020-05-18 |
| DOI：10.11735/j.issn.1004-0242.2020.10.A012 |
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| 中文关键词: 肿瘤 临床试验 方案偏离 观察/评价记录不全 影响因素 |
| 英文关键词:tumor clinical trials protocol deviation incomplete observation / evaluation records influencing factor |
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| 中文摘要: |
| 摘 要：［目的］ 对抗肿瘤药物临床试验中发生观察/评价记录不全方案偏离的影响因素进行分析，探讨各因素对此类方案偏离的影响，提出解决办法，提高项目质量。［方法］ 收集2017—2019年某肿瘤医院开展注册类抗肿瘤药物临床试验项目质量自查发现的467例次观察/评价记录不全方案偏离，影响因素按受试者、研究团队、客观因素、申办方、临床研究协调员（clinical research coordinators，CRC）分类，每个因素再次分组，比较各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］ 2017—2019年注册类抗肿瘤药物临床试验共发生467例次观察/评价记录不全方案偏离，受试者因素引起方案偏离例次最多（193例次，41.44%），与研究协调员有关因素发生方案偏离例次最少（3例次，0.64%）。观察/评价记录不全方案偏离各影响因素统计学差异显著（P=0.000）。受试者因素中，受试者依从性差引起方案偏离发生例次比率最高（140例次，72.54%）；研究团队因素中，研究医生引起方案偏离发生例次比率最高（107例次，78.68%）；客观因素中，假期因素引起方案偏离发生例次比率最高（41例次，49.40%）；申办方因素中，方案设计问题引起方案偏离发生例次比率最高（32例次，61.54%）。各因素分组比较方案偏离发生例次统计学差异显著。［结论］ 抗肿瘤新药临床试验中的安全性评价是抗肿瘤药物上市前临床研究的最关键问题，观察/评价记录不全影响临床试验的安全性数据，提高受试者、研究团队的依从性、制定科学、可操作性强的临床试验方案，为受试者提供便利的就诊条件，为试验配备合格的CRC，是减少观察/评价记录不全方案偏离的有效手段，可提高临床试验质量，保证试验的顺利进行。 |
| 英文摘要: |
| Abstract：［Purpose］ The influencing factors of observation/evaluation records incomplete protocol deviation in clinical trials of antitumor drugs were analyzed to explore the influence of each factor on such protocol deviation，solutions were proposed to improve the project quality. ［Methods］ A total of 467 cases of incomplete observation/evaluation records were collected from a tumor hospital during 2017—2019. The influencing factors according to the subjects，investigate team，objective，sponsor and clinical research coordinator(CRC)，each factor was grouped again，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］ There were 467 cases of incomplete observation/evaluation records protocol deviation in clinical trials of registered anti-tumor drugs from 2017 to 2019. The number of protocol deviations caused by subject factors was the most(193 cases，41.44%)，the protocal deviations due to the CRC was the smallest(3 cases，0.64%). There was statistically significant difference in the influencing factors of incomplete observation/evaluation records(P=0.000). Among the subject factors，protocol deviation caused by poor compliance of subjects had the highest incidence rate(140 cases，72.54%)；among the team factors，the investigate physician caused the highest rate of protocal deviation(107 cases，78.68%)；among the objective factors，the rate of protocal deviation caused by vacation was the highest(41 cases，49.40%)；among the factors of the sponsor，the protocal design caused the highest deviation rate(32 cases，61.54%). There was statistically significant differences in each factor grouping.［Conclusion］ The safety evaluation of new anti-tumor drugs in clinical trials is the most important issue in the pre marketing clinical research of anti-tumor drugs，safety data of clinical trials affected by incomplete observation/evaluation records，improving the compliance of the subjects and the investigate team，developing scientific and feasible clinical trial protocols，providing convenient medical treatment conditions for the subjects，and providing qualified CRC for the trial are effective means to reduce the deviation of incomplete observation/evaluation records protocol deviation，can improve the quality of clinical trials，ensure the smooth progress of the test. |
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