生物等效性试验健康受试者筛选情况分析

Analysis the Cause of the Success or Failure of Screening Healthy Subjects in the Bioequivalence Test

目的归纳分析某院I期临床研究中心生物等效性试验1 041例健康受试者筛选情况,探究影响BE试验健康受试者筛查潜在因素,并制定相应的解决措施,为国内BE试验健康受试者筛查提供理论指导。方法利用Wilcoxon等级和检验方法统计分析该院I期临床研究中心2018年9月~2020年1月参与生物等效性试验的受试者筛选。结果已完成的5项临床试验共筛选受试者1 041人,其中,成功筛选367人(占35.25%);未通过筛选674人(占64.75%)。分析表明实验室检查异常、生命体征检查异常是影响筛选成功率的主要因素。结论开展临床试验宣讲,普及公众临床试验认知;拟定详尽的招募计划与筛选标准,根据试验药物特点制定合适的医学参考值范围;增强潜在受试者自我健康认知,提升国民身体素质,营造"健康中国",是提高筛选成功率的必要因素。

OBJECTIVE To summarize and analyze the screening of 1 041 healthy subjects in the bioequivalence(BE) test of our hospital’s phase 1 clinical research center,to explore the potential factors that affected the screening of healthy subjects in the BE trial,and to formulate corresponding solving approaches,providing therapeutical guidance for screening of the domestic BE trail.METHODS The healthy volunteers from September 2018 to January 2020 who participated in the screening of phase 1 clinical study of our center were analyzed by using the Wilcoxon grade and test method.RESULTS 1 041 healthy volunteers were totally screened in the completed 5 phase 1 clinical studies and 367 volunteers were selected sucessfully.The screening success rate was 35.25%.674 volunteers did not pass the screening,the screening failure rate was 64.75%.Our data indicated that abnormal laboratory examinations and vital signs were the main factors affecting the success of health volunteers screening.CONCLUSION Carrying out BE trial presentations,enhancing BE trial awareness,drawing up detailed recruitment plans and screening standards,formula ting appropriate medical reference value ranges based on the characteristics of the trial drugs;enhancing self-health awareness,improving national physical fitness,and creating a " healthy China",are the imperative factors to improve the screening success rate.