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

doi:10.5246/jcps.2021.09.063

Journal of Chinese Pharmaceutical Sciences ›› 2021, Vol. 30 ›› Issue (9): 754-761.DOI: 10.5246/jcps.2021.09.063

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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.

Abstract

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:

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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References 24

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

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