Construction of breaking the blind risk assessment content for investigator test site in double-blind clinical trials of traditional Chinese medicine and suggestions for maintenance of blinding in clinical trials
YANG Fang-fang
PAN Ding-ju
Abstract：The double-blind trials of tradition Chinese medicine(TCM)are difficult to achieve a strictly defined"double-blind"status due to their particularity.The investigator test site is a key link and specific location in double-blind clinical trials.During the implementation,some research personnel may be aware of the group assignments through their interaction with the experimental drugs.This situation compromises the blinding process for all involved researchers.The implementation of blinding requires stringent adherence to protocols and faces significant difficulties.It is necessary to conduct a comprehensive assessment of the risk on breaking the blinding,along with and the establishment of robust operational guidelines for maintaining blinding.This article constructs an evaluation framework for assessing unblinding risks at TCM double-blind clinical trial sites and offers recommendations and considerations for preserving blinding integrity,in order to provide reference for promoting the construction of industry consensus,optimizing the sponsors'trial plan design,and improving investigators'awareness of blinding.
Keywords：traditional Chinese medicinedouble-blindinvestigatorrisk of breaking the blindmaintenance of blinding
Publication Date：2025-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2526-2530 )