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- W2808141285 abstract "We discuss methods for comparing effects of two treatments A and B. We investigatethe performance of response-adaptive (RA) and covariate-adjusted response-adaptive(CARA) designs in multi-center clinical trials. First, we discuss applying RA designsto maximize the well-being of participating patients in multi-center clinical trials. Weassume that the centers are selected from a large population of centers and develop ageneralized linear mixed model (GLMM) to examine the treatment effect. The asymptoticproperties of the maximum likelihood (ML) estimators of model parameters arederived using the inuence function method. We verified their theoretical propertiesthrough simulation studies. The techniques are then applied to a real data that wereobtained from a multi-center clinical trial designed to compare two cream preparations(active drug/control) for treating an infection. Secondly, we investigate the efficiency for estimates of model parameters and ethics for participating patients amongRA, CARA, and completely randomized (CR) designs for a generalized linear model(GLM). We consider the logit model to measure efficiency and ethics. Furthermore,we showed that ML estimators of GLM parameters are consistent and asymptoticallyfollow multivariate normal distribution for adaptive designs. A simulation study wasconducted to verify these theoretical results. Finally, we provide a justification of whyasymptotic results for Wald-type tests for adaptive designs can be used. We provedthat the choice of adaptive designs affects the statistical power of hypothesis testingvia these quantities: the target allocation proportion, the bias of the randomizationprocedure from the target, and the variability induced by the randomization process.Moreover, we showed that the statistical power increases when the design variabilitydecreases for a covariate in a logit model. Our theoretical findings are verified bysimulation results." @default.
- W2808141285 created "2018-06-21" @default.
- W2808141285 creator A5039012432 @default.
- W2808141285 date "2018-01-01" @default.
- W2808141285 modified "2023-09-23" @default.
- W2808141285 title "Statistical inference for adaptive designs in multi-center clinical trials" @default.
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