Abstract
We consider 2 problems of increasing importance in clinical dose finding studies. First, we assess the similarity of 2 non-linear regression models for 2 non-overlapping subgroups of patients over a restricted covariate space. To this end, we derive a confidence interval for the maximum difference between the 2 given models. If this confidence interval excludes the pre-specified equivalence margin, similarity of dose response can be claimed. Second, we address the problem of demonstrating the similarity of 2 target doses for 2 non-overlapping subgroups, using again an approach based on a confidence interval. We illustrate the proposed methods with a real case study and investigate their operating characteristics (coverage probabilities, Type I error rates, power) via simulation.
Original language | English |
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Pages (from-to) | 722-738 |
Number of pages | 17 |
Journal | Statistics in Medicine |
Volume | 37 |
Issue number | 5 |
DOIs | |
Publication status | Published - 28 Feb 2018 |
Externally published | Yes |
Bibliographical note
Copyright © 2017 John Wiley & Sons, Ltd.Keywords
- Clinical Trials, Phase II as Topic/methods
- Computer Simulation
- Confidence Intervals
- Data Interpretation, Statistical
- Dose-Response Relationship, Drug
- Humans
- Linear Models