New confidence bounds for QT studies |
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Authors: | Boos Dennis D Hoffman David Kringle Robert Zhang Ji |
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Institution: | Department of Statistics, North Carolina State University, P.O. Box 8203, Raleigh, NC 27695-8203, USA. boos@stat.ncsu.edu |
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Abstract: | The proposed guidelines for the assessment of the effect of new pharmaceutical agents on the QT interval (beginning of QRS complex to end of T wave on the electrocardiogram) are based on the maximum of a series over time of simple one-sided 95 per cent upper confidence bounds. This procedure is typically very conservative as a procedure for obtaining a 95 per cent bound for the maximum of the population parameters. This paper proposes new bounds for the maximum, both analytical and bootstrap-based, that are lower but still achieve correct coverage in the context of crossover and parallel designs for the most realistic portions of the parameter space. |
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Keywords: | repolarization arrhythmia electrocardiogram crossover parallel design |
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