Cause analysis of the suspension of drug clinical trials

XIE Zhen-wei; FENG Yu-fei

doi:10.20251/j.cnki.1003-3734.2025.14.010

Abstract：Objective:To conduct an in-depth analysis of suspended drug clinical trials in China,explore the basic characteristics and primary reasons for suspension,and provide scientific decision-making evidence for sponsors,research institutions,and regulatory agencies.Methods:Information on suspended trials from the China Drug Trials Platform was collected,and the drug type,trial scope,indication type,trial registration time,trial phase,distribution of trial centers,and reasons for suspension of suspended projects were analyzed.Results:As of December 31,2023,the platform suspended 448 clinical trial projects,accounting for about 10.65%of the total registered projects.Suspended trials were dominated by chemicals(70.76%),followed by biological products(20.98%)and traditional Chinese medicines/natural medicines(8.26%).In terms of trial phases,bioequivalence trials accounted for the largest number of suspensions(35.04%),followed by Phase Ⅲ(23.66%),Phase Ⅰ(20.54%),and PhaseⅡ(19.20%)trials.The proportion of domestic trials(83.04%)was higher than that of international multi-center trials(16.96%).The main indications of the suspended trials included anticancer(25.22%),cardiovascular and hematological system(18.53%),immune and antimicrobial(10.71%),etc.Among the reasons for suspension,corporate development plans and funding issues were the most prominent(32.59%),followed by unexpected trial results(21.88%)and trial protocol adjustments(12.72%).Differences in reasons for suspension existed among different types of drugs and trial phases,such as unexpected results for bioequivalence trials,while phase Ⅰ～Ⅲtrials were mainly affected by corporate development plans and funding.Conclusion:The phenomenon of suspended drug clinical trials is relatively common in China,with primary reasons including corporate development plans and funding issues,as well as unexpected trial results.Therefore,sponsors,research institutions,and regulatory authorities need to strengthen the supervision and management of clinical trials,optimize resource allocation,reduce unnecessary trial suspensions,and safeguard the rights and interests of subjects while promoting efficient drug research and development.