生物等效性试验中健康受试者的脱落原因及主动脱落相关因素分析

• 作 者: 余恒毅 方一念 王开付 陈倩 杜艾桦 任秀华 刘东
• 机 构: 华中科技大学同济医学院附属同济医院药学部,湖北武汉430030;华中科技大学同济医学院附属同济医院Ⅰ期临床试验研究室,湖北武汉430030;华中科技大学同济医学院附属同济医院Ⅰ期临床试验研究室,湖北武
• 出 处: 中国药学（英文版）
• 发表日期: 2021年9期
• 关键词: Dropout Healthy participant Reason Associated factor Bioequivalence study

避免参加临床试验的受试者脱落有助于临床试验的顺利开展,同时节省时间、经费和其他资源.自2015年以来,我国针对仿制药一致性评价工作开展了大量的生物等效性(BE)试验,但尚无健康志愿者脱落相关的研究报道.本次回顾性研究中,我们纳入了2016年3月至2019年2月间在我中心开展的18项BE试验的1078名健康志愿者,通过记录每位受试者的人口学资料和临床试验信息,对生物等效性试验中健康受试者的脱落原因及主动脱落相关因素进行分析.结果 显示,依从性差、发生不良事件和失访是受试者脱落的三大主要原因,占全部脱落的78.7％;吸烟习惯(OR=5.790,P＜0.001)与受试者主动脱落的风险增加显著相关,而年龄增长(OR=0.940,P=0.042)和非SAE的不良事件(OR=0.321,P=0.004)与受试者主动脱落的风险降低显著相关.加强对年轻受试者和有吸烟习惯受试者的教育,并向受试者强调研究药物的潜在的不良反应和风险可能是减少健康受试者主动脱落的有效策略.“,”Maintaining participants in a trial ultimately without dropout helps keep a study on track,saving time,money,and resources.Since 2015,extensive bioequivalence (BE) studies have been carried out in China,while no research about dropout in healthy volunteers has been reported yet.In this retrospective study,1078 healthy volunteers participating in 18 BE studies from March 2016 to February 2019 in one Chinese hospital were included.Information about the healthy participants and BE studies was recorded for analysis.In terms of the dropout reason,poor compliance,adverse event (AE),and loss of follow-up were found to be the three leading causes of dropout,accounting for 78.7％ of all dropouts.In terms of associated factors with active dropout,smoking habit (OR =5.790,P ＜ 0.001) was significantly associated with increased risk of active dropout,while older age (OR =0.940,P =0.042) and AE except for SAE (OR =0.321,P =0.004) were significantly associated with a decreased risk of active dropout.Strengthening the education on younger participants and participants with a smoking habit,as well as emphasizing the possible adverse reactions and potential risks,might be strategies to reduce active dropout in healthy participants.