Experience with Refined Quality Control in Multicenter Clinical Trials of Acupuncture
- VernacularTitle:针灸多中心临床试验的精细化质量控制经验
- Author:
Linxi SUN
1
;
Xuqiang WEI
1
;
Ke WANG
1
;
Jia ZHOU
1
Author Information
- Publication Type:Journal Article
- Keywords: Acupuncture; Multicenter clinical studies; Quality control; IIT; Bias
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(9):2453-2460
- CountryChina
- Language:Chinese
- Abstract: As evidence-based medicine advances and the number of published acupuncture clinical trials in international journals increases,the quality of these trials has become a major focus.The inherent diversity,complexity,and individualization of acupuncture treatments pose unique challenges for quality control in multicenter clinical studies,particularly in Investigator-Initiated Trial(IIT).Refined quality control is essential for the successful conduct of multicenter clinical trials in acupuncture.This study uses the multicenter clinical trials of acupuncture led by our research group as a case study to summarize the quality control experiences throughout the entire process of multicenter IITs.It synthesizes quality control strategies across the trial lifecycle,examines the management of key elements such as participants,materials,data,and specimens,and discusses project design,process management,protocol adherence,and subject safety.These insights are intended to enhance the scientific rigor and reliability of the trials,providing a reference and point of view for researchers in future similar studies.
