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

Yi, D, Wu, S, Zi, W et al. (2022). Clinical trial design for revascularization in acute stroke due to anterior circulation large vessel occlusion: A comparative study on 6 trials . 44(11), 1143-1148. 10.16016/j.2097-0927.202201022

cited authors

  • Yi, D; Wu, S; Zi, W; Chen, J; Wu, Y

authors

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.

publication date

  • June 15, 2022

Digital Object Identifier (DOI)

start page

  • 1143

end page

  • 1148

volume

  • 44

issue

  • 11