Model selection versus model averaging in dose finding studies
| Autor: | Holger Dette, Kirsten Schorning, Björn Bornkamp, Frank Bretz |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Statistics and Probability
Mathematical optimization Epidemiology business.industry Model selection Function (mathematics) 01 natural sciences 3. Good health 010104 statistics & probability 03 medical and health sciences Dose finding 0302 clinical medicine Drug development Sample size determination Statistics Medicine In patient 030212 general & internal medicine 0101 mathematics Constant (mathematics) business Dose selection |
| Zdroj: | Statistics in Medicine. 35:4021-4040 |
| ISSN: | 0277-6715 |
| DOI: | 10.1002/sim.6991 |
| Popis: | A key objective of Phase II dose finding studies in clinical drug development is to adequately characterize the dose response relationship of a new drug. An important decision is then on the choice of a suitable dose response function to support dose selection for the subsequent Phase III studies. In this paper, we compare different approaches for model selection and model averaging using mathematical properties as well as simulations. We review and illustrate asymptotic properties of model selection criteria and investigate their behavior when changing the sample size but keeping the effect size constant. In a simulation study, we investigate how the various approaches perform in realistically chosen settings. Finally, the different methods are illustrated with a recently conducted Phase II dose finding study in patients with chronic obstructive pulmonary disease. Copyright © 2016 John Wiley & Sons, Ltd. |
| Databáze: | OpenAIRE |
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