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This prematurely terminated trial failed to show the anticipated increase in OS with MA over placebo, and patients on placebo generally had better outcomes in terms of QOL.
In a recently published, prematurely terminated trial, the use of HIV-entry inhibitor cellulose sulphate did not prevent, but might have increased the risk of HIV transmission (van Damme et al., 2008).
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We terminated trials either after food retrieval, if five minutes had elapsed, or if the subject left the testing room for longer than 1 minute.
Three out of the five terminated trials were neonatal RCTs.
No relevant completed or terminated trials were registered.
Then, ongoing and terminated trials were removed based on their status and/or trial reports.
DMCs and interim analysis were mentioned in 21/32 (66%) and 22/32 (69%) of early terminated trials, respectively.
The frequency of reported early terminated trials in this sample was 21% (14/68) in general journals and 43% (18/42) in pediatric journals.
In particular, equipoise provides flawed ethical guidance for placebo-controlled trials and for decisions to terminate trials early based on interim data relating to benefit.
In summary, compared with the Simon optimal two-stage designs, our proposed BHT-A design can terminate trials of unpromising doses early, by utilizing a continuous monitoring rule and nonlocal alternative prior distributions in the hypothesis tests.
A premature saccade outside the fixation window immediately terminated the trial without reward; aborted trials were discarded from all data analyses.
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