One-sided Simultaneous Confidence Intervals for Effective Dose Steps in Unbalanced Designs
✍ Scribed by Ludwig A. Hothorn; Frank Bretz
- Publisher
- John Wiley and Sons
- Year
- 2000
- Tongue
- English
- Weight
- 108 KB
- Volume
- 42
- Category
- Article
- ISSN
- 0323-3847
No coin nor oath required. For personal study only.
✦ Synopsis
An important issue in dose finding is whether a further dose increment leads to a relevant increase in efficacy. Clinical efficacy should not be considered by point zero null hypotheses. Instead, shifted hypotheses for the difference or the ratio can be used. Because the a priori definition of a relevance threshold is frequently difficult, confidence intervals should be used for a posteriori interpretation. Sample size estimationa-priori or by adaptive interim analysis-is inherent, because the effective dose steps are arbitrary in un-designed studies.
For simultaneous confidence intervals without order restriction the exact distributions under the null and the alternative hypothesis is proposed for the general unbalanced one-way design.