Use of the average baseline versus the time-matched baseline in parallel group thorough QT/QTc studies.
J Biopharm Stat
; 20(3): 665-82, 2010 May.
Article
em En
| MEDLINE
| ID: mdl-20358444
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Arritmias Cardíacas
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Ensaios Clínicos Controlados Aleatórios como Assunto
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Modelos Estatísticos
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Frequência Cardíaca
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
J Biopharm Stat
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos