Discussion on the rights of subjects after termination of clinical trials for anticancer drugs

YANG Feng; YANG Wan-shuang; GONG Qian

doi:10.20251/j.cnki.1003-3734.2025.05.010

Abstract：Objective:To explore the medical disposition measures for subjects after the termination of clinical trials for anticancer drugs,in order to safeguard the rights and interests of these subjects after the trial ends.Methods:Our study collected fundamental information of 272 anticancer drug clinical trials that were terminated by sponsors between 2020 and 2023.We initially summarized the primary reasons for trial termination,followed by a detailed analysis of the factors influencing unexpected terminations of clinical trials.Finally,we engaged in discussions regarding the clinical characteristics of subjects who remained enrolled in the trial at the time of the terminations.Results:Among the 272 anticancer drug clinical trials,unexpected terminations accounted for 73.9%(201/272)of cases.The most common reason for trial termination was sponsor-initiated cessation of drug development,which accounted for 38.8%.At the time of termination,subjects still receiving drug treatment in clinical trials comprised 4.2%(3/71)in the expected termination group and 14.4%(29/201)in the unexpected termination group,indicating a higher proportion in the unexpected termination trials(P=0.022).Amongtheseaffectedby trial terminations,78.1%(25/32)of clinical trial sponsors continued to provide the investigational drug treatment at no cost for subjects who were still benefiting from it after trial termination.Among advanced first-line treatment subjects,a notable 56.6%(64/113)continued the investigational drug treatment after trial termination,while only 21.4%(3/14)discontinued it,reflecting a higher continuation rate among first-line treatment subjects(P=0.002).In terms of partial remission at the point of termination,39.8%(45/113)continued their investigational drug treatment after trial termination,whereas only 14.3%(2/14)ceased the treatments,demonstrating a higher proportion of those with partial remission continuing the drug(P=0.024).Conclusion:During the conduct of clinical trials for new anticancer drugs,a considerable proportion of subjects may continue benefiting from drug treatment even when the trial is unexpectedly terminated,most of whom were subjects receiving first-line treatment or experiencing partial relief.Ethics committees should advocate for these subjects still in the trial to have the opportunity to access trial drugs after the trial ends to safeguard their rights and interests.