Why the study?
Does recording 3 or 4 replicate ECGs at each time point optimize sample size and study cost compared to other numbers of replicates in thorough QT studies?
Population
124 normal healthy volunteers from a thorough QT/QTc (TQT) study
Comparison
3 or 4 replicate ECGs recorded at each time point vs 1, 2, 5, or 6 replicate ECGs recorded at each…
Design
Other, Randomized to receive moxifloxacin or placebo on day 1 and the other…
Follow-up
3 days
Authors
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May reduce costs in thorough QT studies without sample size penalty; leaves open need for prospective validation.
Does recording 3 or 4 replicate ECGs at each time point optimize sample size and study cost compared to other numbers of replicates in thorough QT studies?
In thorough QT studies, recording 3 or 4 replicate ECGs per time point provides the optimal balance between reducing within-subject variability and minimizing study costs.
Natekar et al. (2010) studied this question.
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