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Publishing Language: Chinese

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

Dali YI1,2, Shuxing WU3, Wenjie ZI4, Ji'an CHEN2, Yazhou WU1( )
Department of Health Statistics, Army Medical University (Third Military Medical University), Chongqing, 400038
Department of Health Education, Army Medical University (Third Military Medical University), Chongqing, 400038
Dean's Office, Faculty of Military Preventive Medicine, Army Medical University (Third Military Medical University), Chongqing, 400038
Department of Neurology, Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China
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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.

Keywords

revascularizationclinical trialsdesign protocolcomparative study
CLC number: R195.1;R741.05;R743.33 Document code: A

References

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Journal of Army Medical University
Volume 44 Issue 11,
June 2022
Pages 1143-1148
DOI: 10.16016/j.2097-0927.202201022

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Cite this article:
YI D, WU S, ZI W, et al. 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, 2022, 44(11): 1143-1148. https://doi.org/10.16016/j.2097-0927.202201022

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Received: 04 January 2022
Revised: 24 January 2022
Published: 15 June 2022
© 2022 Journal of Army Medical University