某院生物等效性试验健康受试者筛选失败原因分析

Analysis of the Reasons for the Failure of Screening Healthy Subjects in the Bioequivalence Test in the Hospital and Discussion of Some Common Problems

目的对某院开展的生物等效性试验中健康受试者筛选情况进行分析,探讨受试者筛选失败的原因。方法总结分析2019年1月~2020年5月在该院开展的8项生物等效性试验健康受试者临床资料。结果筛败因素包括生命体征、实验室检查、BMI、心电图检查等,其中占比最大的是实验室检查不合格(47.43%),其次为生命体征异常(14.54%)和BMI不合格(9.40%)。结论实验室检查是造成筛选失败的最主要原因,生命体征和依从性也严重影响筛选的成败。研究者应加强重视筛选过程中出现的各种问题,以提高筛选成功率。

OBJECTIVE To analyze the screening of healthy volunteers and explore the causes of screening failure in the bioequivalence test in our hospital.METHODS Clinical subject data of the healthy volunteers in 8 bioequivalence test carried out in our hospital form January 2019 to May 2020 were analyzed.RESULTS The factors for the screening failure included vital signs,laboratory examination,BMI,electrocardiograms and so on.Unqualified laboratory examination(47.43%)was accounted for the largest proportion,followed by abnormal vital signs(14.54%)and BMI(9.40%).CONCLUSION Laboratory examination is the main cause of screening failure,vital signs and compliance also seriously affect the success of screening.The researchers should attach importance to the issues in screening to improve the success rate.