Analysis of the Causes of Subject Screening Failures in Clinical Trials of Antineoplastic Drugs and Protocol Nerfing Indicators
10.3870/j.issn.1004-0781.2025.03.030
- VernacularTitle:抗肿瘤药物临床试验受试者筛选失败原因及方案纳排指标分析
- Author:
Shuopeng JIA
1
;
Hailan MA
;
Huiyao HUANG
;
Jingxiao ZHU
;
Anqi YU
;
Yiru HOU
;
Yu TANG
;
Hong FANG
;
Ning LI
Author Information
1. 国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京 100021
- Publication Type:Journal Article
- Keywords:
Antineoplastic drugs;
Clinical trial protocols;
Inclusion exclusion criteria;
Screening failure reasons;
Sub-jects
- From:
Herald of Medicine
2025;44(3):497-502
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being＜65 years of age(333,78.4％),of which the most important reasons included vol-untary withdrawal(71,16.7％),tumor metastasis(52,12.2％),failure to recover from treatment of pre-existing disease(38,8.9％),failure of bone marrow function(19,4.5％),and non-compliant liver function(15,3.5％).Among the nadir indicators,the age of the subjects(100％),ECOG score(97.5％),bone marrow function(ANC:95.0％,PLT:97.5％,HB:97.5％),liver function(T-BiL:95.0％,ALT:87.5％,AST:95.0％),renal function(CR:80.0％),and viral screening(HIV:80.0％,HBV:70.0％,HCV:62.5％)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.
