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 researc...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.展开更多
基金National Major Scientific and Technological Special Project for Significant New Drugs Development(Grant No.2017ZX09304022)。
文摘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.
