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Stat Med. 2009 Oct 30;28(24):2941-51. doi: 10.1002/sim.3684.

An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dose-finding study.

Author information

1
Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7420, USA. aivanova@bios.unc.edu

Erratum in

  • Stat Med. 2010 Dec 20;29(29):3068.

Abstract

Proof-of-concept in clinical trials has traditionally focused on the identification of a maximum tolerated dose with the assumption that the higher doses provide better efficacy. However, adverse events associated with a maximum tolerated dose may have a negative effect on efficacy. We present an efficient adaptive dose-finding strategy that concentrates patient assignments at and around the dose which has the best efficacy/tolerability profile based on a utility function. The strategy is applied within the setting of a crossover design. While the strategy may also be applied to parallel studies, a crossover design provides more power for a given sample size for comparisons between the optimal dose versus placebo and/or active control when it is reasonable to assume no carryover effects.

PMID:
19731265
PMCID:
PMC2772210
DOI:
10.1002/sim.3684
[Indexed for MEDLINE]
Free PMC Article
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