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

doi:10.5246/jcps.2021.09.063

中国药学(英文版) ›› 2021, Vol. 30 ›› Issue (9): 754-761.DOI: 10.5246/jcps.2021.09.063

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

余恒毅¹^,²^,^#, 方一念¹^,²^,^#, 王开付², 陈倩¹^,², 杜艾桦³, 任秀华¹^,²^,^*(), 刘东¹^,²^,^*()

1. 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
2. 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
3. 华中科技大学同济医学院附属同济医院科研处, 湖北武汉 430030

收稿日期:2021-03-14 修回日期:2021-04-07 接受日期:2021-04-21 出版日期:2021-09-27 发布日期:2021-09-27
通讯作者: 任秀华, 刘东
作者简介:
+ Tel.: +86-27-69378207, E-mail: 271052026@qq.com
+ Tel.: +86-27-83663643, E-mail: ld2069@outlook.com
基金资助:
National Major Scientific and Technological Special Project for Significant New Drugs Development (Grant No. 2017ZX09304022).

Dropout reasons and associated factors with active dropout in Chinese healthy participants of bioequivalence studies

Hengyi Yu¹^,²^,^#, Yinian Fang¹^,²^,^#, Kaifu Wang², Qian Chen¹^,², Aihua Du³, Xiuhua Ren¹^,²^,^*(), Dong Liu¹^,²^,^*()

1 Department of pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
2 Phase I Clinical Trial Unit, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
3 Department of Scientific Research Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

Received:2021-03-14 Revised:2021-04-07 Accepted:2021-04-21 Online:2021-09-27 Published:2021-09-27
Contact: Xiuhua Ren, Dong Liu
About author:
# Hengyi Yu and Yinian Fang contributed equally to this work.

摘要/Abstract

摘要：

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。

关键词: 脱落, 健康受试者, 原因, 相关因素, 生物等效性试验

Abstract:

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.

Key words: Dropout, Healthy participant, Reason, Associated factor, Bioequivalence study

Supporting:

余恒毅, 方一念, 王开付, 陈倩, 杜艾桦, 任秀华, 刘东. 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[J]. 中国药学(英文版), 2021, 30(9): 754-761.

Hengyi Yu, Yinian Fang, Kaifu Wang, Qian Chen, Aihua Du, Xiuhua Ren, Dong Liu. Dropout reasons and associated factors with active dropout in Chinese healthy participants of bioequivalence studies[J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(9): 754-761.

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参考文献 24

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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

Dropout reasons and associated factors with active dropout in Chinese healthy participants of bioequivalence studies

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