Key result
The five-period crossover design for thorough QT studies can increase standard errors by up to 13% compared to the four-period design when realistic treatment correlations are considered.
The assumption that a five-period crossover TQT design reduces sample size is flawed because it ignores within-subject correlation, making the four-period design more efficient in practice.
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Chen et al. (2026) conducted a letter in Thorough QT (TQT) studies. Five-period crossover design vs. Four-period crossover design was evaluated on Standard error ratio. The five-period crossover design for thorough QT studies can increase standard errors by up to 13% compared to the four-period design when realistic treatment correlations are considered.
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