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Exact(5)
Recruitment ended before the planned sample size of 36 subjects had been enrolled, as it was not possible to extend the expiry date for FP85A.
Of the eligible GPs, 358 participated and completed the survey and provided select patient results before the planned sample size was achieved.
Deviations of intervention effects far from the anticipated values should a priori be regarded as unlikely and this is one reason for using a lower statistical threshold to stop a trial before the planned sample size has been reached [ 33].
As we had decided to prematurely close the case accrual before the planned sample size of patients had been reached, we may speculate that these findings may be due to the low power of the test performed on a small patient population.
An interim futility analysis was performed, and it was concluded that there were neither scientific nor ethical reasons to continue enrolling patients for an additional 2-3 yeand, asd as a result, the study was terminated prematurely, before the planned sample size population was reached.
Similar(55)
Both the phase III trials were stopped before enrolment of the planned sample size because of slow accrual.
Noteworthy, both studies were also stopped before completion of the inclusion of the planned sample size (25%and73%3% of planned samples, respectively).
We define a 'discontinued RCT' as any RCT that was stopped before reaching at least 90% of the planned sample size due to any reason, including futility, adverse events (harm), early evidence of superiority of one intervention (benefit) and insufficient recruitment (a cut-off at 80% of the planned sample size will be considered in a sensitivity analysis).
The planned sample size was not reached due to accrual slower than anticipated [27].
When designing a study, the planned sample size is often based on power analyses.
The planned sample size was 60 participants.
Related(20)
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