An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dose-finding study.
An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dose-finding study.
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DOI：
10.1002/sim.3684
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发表时间：
2009-10-30
影响因子：
2
通讯作者：
Snavely, Duane
中科院分区：
文献类型：
--
作者：
Ivanova, Anastasia;Liu, Ken;Snyder, Ellen;Snavely, Duane
Proof-of-concept in clinical trials has traditionally focused on 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 which 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.
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DOI：
10.3109/10601338609051233
发表时间：
1986-01-01
期刊：
Clinical Research Practices and Drug Regulatory Affairs
影响因子：
--
作者：
DUBEY S D
通讯作者：
DUBEY S D
影响因子：
1.9
作者：
Ivanova, A
通讯作者：
Ivanova, A
影响因子：
2
作者：
Ivanova, Anastasia;Bolognese, James A.;Perevozskaya, Inna
通讯作者：
Perevozskaya, Inna
影响因子：
1.9
作者：
O'Quigley, J;Hughes, MD;Fenton, T
通讯作者：
Fenton, T
DOI：
10.1071/ch9490149
发表时间：
1949-01-01
期刊：
AUSTRALIAN JOURNAL OF SCIENTIFIC RESEARCH SERIES A-PHYSICAL SCIENCES
影响因子：
--
作者：
WILLIAMS, EJ
通讯作者：
WILLIAMS, EJ