PDF
Full
Outline
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.
PDF
34
12
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
