Analysis and consideration of classification for the causality assessment of adverse events in drug clinical trials
PEI Xiao-jing
LI Hai-yan
SHEN Yi-feng
LIU Min
Abstract：The evaluation of causality assessment between an adverse event and a drug plays a critical role in safety research and risk management in clinical trials.At present,there is a lack of unified and standardized classification methods and requirements for adverse event causality assessment in the clinical trials internationally.In order to standardize relevant work,in 2024,the Center for Drug Evaluation issued the"Technical Guideline for Causality Assessment of Adverse Events in Drug Clinical Trials(interim)",which provides technical references for the classification methods in China.This article introduces the research background and analytical approach to better understand and apply the relevant content of the Guideline.
Keywords：drug clinical trialadverse eventcausality assessmentclassification
Publication Date：2026-03-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 476-480 )