仿制药生物等效性试验受试者筛选合格率的提高方法

A Method for Improving the Qualified Rate of Subject Screening in Bioequivalence Trial of Generic Drug

目的提高仿制药生物等效性试验受试者筛选的合格率。方法收集医院2018年至2020年Ⅰ期临床研究室2项阿立哌唑片仿制药生物等效性试验(试验一和试验二)受试者的招募和筛选信息,其中试验一共招募244例受试者,试验二共招募131例受试者。在获取受试者联系方式后,试验一直接与受试者预约知情同意时间;试验二提前预约受试者来院或通过网络初筛,合格后进入试验筛选群进行统一管理。比较两项试验受试者的筛选合格率,并分析导致筛选失败的原因。结果2项试验受试者人口学特征比较均无显著差异(P>0.05);试验二的筛选合格率为54.96%,显著高于试验一的43.44%(P<0.05)。导致筛选失败的原因包括各类检查(如实验室检查、12导联心电图检查)、个人史、生命体征、体质量指数、撤回知情同意和其他,其中主要原因为各类检查筛选失败,试验一和试验二分别占27.05%和25.19%;次要原因试验一和试验二分别为个人史和生命体征,分别占12.70%和11.45%。结论提前预知情的管理方法用于仿制药生物等效性试验受试者招募和筛选,有利于提高受试者的筛选合格率,但筛选合格率仍有较大提升空间。

Objective To improve the qualified rate of subject screening in bioequivalence trial of generic drug.Methods The recruitment and screening information of subjects in two bioequivalence trials of generic drug Aripiprazole Tablets(trialⅠand trialⅡ)in the phaseⅠclinical laboratory of the hospital from 2018 to 2020 was collected,with 244 subjects in trialⅠand 131 subjects in trialⅡ.After the contact methods were obtained,subjects in trialⅠwere directly made an appointment for the informed consent time,while subjects in trialⅡwere scheduled to come to the hospital in advance or participate in the preliminary screening through the Internet,and the qualified subjects would be included in a screening group for unified management.The qualified rates of subject screening in the two trials were compared,and the reasons for failed screening in the two trials were analyzed.Results There was no significant difference in demographic characteristics between the two trials(P>0.05).The qualified rate of screening in the trialⅡwas 54.96%,which was significantly higher than 43.44%in the trial I(P<0.05).The reasons for failed screening included various examinations(such as laboratory examination and 12-leads electrocardiogram examination),personal history,vital signs,body mass index,withdrawal of informed consent and others.The main reason was the failure of various examination in trialⅠ(27.05%)and trialⅡ(25.19%),followed by personal history in trialⅠ(12.70%)and vital signs in trialⅡ(11.45%).Conclusion The application of management method of knowing in advance in the recruitment and screening of subjects in the bioequivalence trial of generic drug is beneficial to improve the qualified rate of subject screening,but there is still a large room for improvement in the qualified rate of screening.