Abstract：Objective To analyze the main reasons of the screening failure, explore the strategies for improving the success rate of screening, in order to provide the reference frame for research institute and sponsor making recruitment plan. Methods From January 2013 to October 2016, in Affiliated Hospital of Guizhou Medical University, the data of drug clinical trial program were selected, the clinical trial research teams and subjects were given interview. The data statistics described by SPSS 19.0 statistical software. Results There were 47 drug clinical trials were involved, 958 subjects were screened, and 182 of them were screening failed. 54 subjects (29.67%) were physical examination results did not meet the inclusion criteria or met exclusion criteria; 48 subjects (26.37%) withdrew informed consent forms before enrolling; 40 subjects (21.98%) failed during run-in period; 35 subjects (19.23%) were laboratory indicators met the exclusion criteria or did not meet the inclusion criteria; 5 subjects (2.75%) were screening failed for other reasons. Conclusion The main reasons for failure of subjects screening are that the physical examination results do not meet the requirements of the drug clinical trials and the withdrawing of the informed consent forms. If a run-in period is designed in a clinical trial, there is a higher risk of screening failure in the run-in period. Formulating scientific and feasible screening scheme, drawing up reasonable and feasible recruitment plan, more training investigators, increasing knowledge popularization of clinical trials, they are all helpful for recruitment and improving the success rate of screening in drug clinical trials.
刘琳 何艳 周岩 李娜 曾艳 张倩. 我院药物临床试验受试者筛选失败原因分析及对策[J]. 中国医药导报, 2019, 16(6): 177-180.
LIU Lin HE Yan ZHOU Yan LI Na ZENG Yan ZHANG Qian. Causes analysis and countermeasures of screening failure in drug clinical trials. 中国医药导报, 2019, 16(6): 177-180.
2019, Vol. 16 
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