伦理审查视角下抗肿瘤药物临床试验方案违背的回顾性分析

Retrospective analysis on protocol violation of anti⁃tumor drug clinical trials from the perspective of ethical review

从伦理审查角度分析抗肿瘤药物临床试验方案违背发生的规律、特点与原因。回顾性分析2018—2021年在北京大学肿瘤医院开展的抗肿瘤药物临床试验发生的方案违背次数和类别,并按不同科室、临床试验开展范围(国内与国际)分组进行比较,同时分析方案违背的影响。2018—2021年在本院开展的抗肿瘤药物临床试验发生方案违背1 256次,持续方案违背发生次数最多(318次,25.32%)、研究者不配合监查/稽查发生次数最少(6次,0.50%)。内科和外科、国内研究和国际研究之间比较方案违背发生次数的差异均具有统计学意义(P<0.01)。方案违背对受试者的安全、权益以及试验结果产生影响的比例分别为5.81%,4.78%和5.41%。抗肿瘤药物临床试验过程中有可能会发生各种方案违背,可以通过加强质量控制、对研究团队和受试者进行有针对性的培训来尽量减少其发生,提高药物临床试验的质量。

To analyze the pattern,characteristics and causes of protocol violation in anti⁃tumor drug clinical trials from the perspective of ethical review.The number and categories of violation projects were retrospectively analyzed and compared in different departments and the area of clinical trials(domestic or international).The impact of protocol violation on clinical trials carried out in our hospital from 2018 to 2021 was also analyzed.From 2018 to 2021,1256 protocol violation cases occurred in clinical trials of anti⁃tumor drugs carried out in our hospital.The number of continuous protocol violations(318,25.32%)was the largest,and the number of researchers'failure to cooperate with supervision/audit(6,0.50%)was the fewest.The difference in the number of protocol violation between internal and surgical,domestic and global clinical trials were both statistically significant(P<0.01).The proportion of protocol violations affecting the safety,rights of subjects and trials results were 5.81%,4.78%and 5.41%,respectively.Various protocol violations may occur during clinical trials of anti⁃tumor drugs.In order to improve the quality of clinical trials,it can be effectively avoided by strengthening quality control and conducting targeted training for the research team and subjects.