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急性前循环颅内大血管闭塞血运重建临床试验设计比较研究
Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: a comparative study on 6 trials
- 陆军军医大学学报 2022年44卷第11期 页码：1143-1148
- 作者机构：
1.400038 重庆, 陆军军医大学(第三军医大学): 军事预防医学系军队卫生统计学教研室
2.400038 重庆, 陆军军医大学(第三军医大学): 军事预防医学系军队健康教育学教研室
3.400038 重庆, 陆军军医大学(第三军医大学): 军事预防医学系系办公室
4.400037 重庆, 陆军军医大学(第三军医大学)第二附属医院神经内科
- 作者简介：
[伍亚舟, E-mail: asiawu@tmmu.edu.cn WU Yazhou, E-mail: asiawu@tmmu.edu.cn
- 基金信息：国家自然科学基金项目(81872716);国家自然科学基金项目(82173621);重庆市自然科学基金重点项目(cstc2020jcyj-zdxmX0017);陆军军医大学基础研究课题(2021-2018-037)
DOI：10.16016/j.2097-0927.202201022
中图分类号： R195.1;R741.05;R743.33收稿：2022-01-04，
修回：2022-01-24，
纸质出版：2022-06-15
- 稿件说明：
移动端阅览
易大莉, 武书兴, 资文杰, 等. 急性前循环颅内大血管闭塞血运重建临床试验设计比较研究[J]. 陆军军医大学学报, 2022,44(11):1143-1148.
Dali YI, Shuxing WU, Wenjie ZI, et al. Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: a comparative study on 6 trials[J]. Journal of Army Medical University, 2022, 44(11): 1143-1148.
易大莉, 武书兴, 资文杰, 等. 急性前循环颅内大血管闭塞血运重建临床试验设计比较研究[J]. 陆军军医大学学报, 2022,44(11):1143-1148. DOI： 10.16016/j.2097-0927.202201022.
Dali YI, Shuxing WU, Wenjie ZI, et al. Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: a comparative study on 6 trials[J]. Journal of Army Medical University, 2022, 44(11): 1143-1148. DOI： 10.16016/j.2097-0927.202201022.
摘要
目的
2
通过6个比较是否用药溶栓的急性前循环颅内大血管闭塞血运重建临床试验，对临床试验设计方案和试验结果进行比较分析，以期提高临床研究者对临床试验设计重要性的全面认识。
方法
2
围绕临床试验设计的要点，针对研究人群、对照选择、主要指标、比较类型、样本含量估计等方面，分析其合理性和科学性。
结果
2
6个临床试验设计均存在一定的问题，从而导致4个试验的主要指标未达到显著性检验标准。主要问题是：研究人群与研究目标不符，采用了不合理的优效性比较类型，样本含量估计参数选取不合理，非劣效界值设定不符合最小临床重要差异等。
结论
2
临床试验设计还存在许多误区，需要进一步提高认识和重视程度。
Abstract
Objective
2
To compare and analyze clinical trial design protocols and results of 6 clinical trials concerning revascularization in acute stroke due to anterior circulation large vessel occlusion in order to improve clinical researchers′ comprehensive understanding on the importance of clinical trial design.
Methods
2
As for the key points of clinical trial design
rationality and scientificity of the designs in term of study population
control selection
main indexes
comparison type and sample size estimation were analyzed.
Results
2
There were some problems in the design of 6 clinical trials. As a result
the main indexes of the 4 trials did not meet the significance test standards. The main problems were as following: study population inconsistent with the study objectives
adoption of unreasonable superiority comparison
unreasonable selection for parameters of sample size estimation
and non-inferiority margin setting not meeting the minimum clinically important difference.
Conclusion
2
There are still many misunderstandings in clinical trial design
which need further awareness and attentions.
关键词
Keywords
references
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