生物等效性试验健康受试者筛选流程的优化

目的 探讨如何提高生物等效性试验健康受试者筛选期的工作效率.方法 试验甲给予受试者根据各个检查项目等待人数自由分流的筛选方法;试验乙给予对部分检查项目进行先后顺序限定,并要求研究者在发现受试者某项检查结果异常后,应及时终止其继续参加其他检查的筛选方法.比较2个试验中受试者在某项检查不合格时合并有其他项目检查的情况.结果...

Optimization of screening process for healthy subjects in bioequivalence trials

Objective To investigate how to improve the efficiency of screening healthy subjects in bioequivalence test. Methods The trial A applied a screening method of free triage according to the number of subjects waiting for each inspection item, while trial B adopted a screening method in which the sequence of several inspection items was limited and the researchers were required to terminate subject’s participation in screening immediately if any abnormal test results appeared. The situation of combining other items when a certain inspection was unqualified was compared between two groups. Results The incidence of trial A that subjects failed weight, vital signs, inquiry and physical examination but combined with other inspection items was higher than that of trial B. During the screening process, trial A was found to have a phenomenon that multiple abnormal examination results occurred in a same subject,which led to the waste of medical resources. After optimizing the screening process, trial B could preferentially eliminate unqualified subjects in efficient, low-cost and non-invasive examination programs. Thus the rights of subjects were protected preferably and the costs of clinical trials screening are reduced. Conclusion The subjects screening process of trial B is superior to trial A as a whole, which is beneficial for the smooth development of clinical trial recruitment.