Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: a comparative study on 6 trials

Dali YI; Shuxing WU; Wenjie ZI; Ji′an CHEN; Yazhou WU

doi:10.16016/j.2097-0927.202201022

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Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: a comparative study on 6 trials

Clinical Medicine | 更新时间：2026-01-09

- Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: a comparative study on 6 trials
- Journal of Army Medical University Vol. 44, Issue 11, Pages: 1143-1148(2022)
- 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：
- 基金信息：
  
  the National Natural Science Foundation of China(81872716);the National Natural Science Foundation of China(82173621);the Natural Science Foundation of Chongqing(cstc2020jcyj-zdxmX0017);the Basic Research Project of Army Medical University(2021-2018-037)
- DOI：10.16016/j.2097-0927.202201022
  CLC： R195.1;R741.05;R743.33
- Received：04 January 2022，
  
  Revised：2022-01-24，
  
  Published：15 June 2022
- 稿件说明：
移动端阅览
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：

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

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

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

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

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

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

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

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

There are still many misunderstandings in clinical trial design

which need further awareness and attentions.

关键词

Keywords

references

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Neuroscience Trials Australia. DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval. ClinicalTrials. gov Identifier: NCT03494920[EB/OL]. (2021-07-29)[2022-06-07]. https://clinicaltrials.gov/ct2/show/NCT03494920.

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