Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 20, Issue 3, Pages 665-682Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543400903582067
Keywords
ANCOVA; ANOVA; Bias; Diurnal effect correction; Efficiency
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Using historical studies, we compared the impact of using the average baseline or time-matched baseline on diurnal effect correction, treatment effect estimation, and analysis of variance/covariance (ANOVA/ANCOVA) efficiency in a parallel thorough QT/QTc (TQT) study. Under a multivariate normal distribution assumption, we derived conditions for achieving unbiasness and better efficiency when using the average baseline, and confirmed these conditions using historical TQT studies. Furthermore, simulations were conducted under the randomized trial with and without observed imbalanced baseline settings. We conclude that the analyses using average baseline yield better efficiency and unbiased or less biased results under our TQT study conditions.
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