Model-Based Assessment of Alternative Study Designs in Pediatric Trials. Part I: Frequentist Approaches.
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ABSTRACT:
SUBMITTER: Smania G
PROVIDER: S-EPMC5131885 | biostudies-literature | 2016 Jun
REPOSITORIES: biostudies-literature
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Model-Based Assessment of Alternative Study Designs in Pediatric Trials. Part I: Frequentist Approaches.
Smania G G Baiardi P P Ceci A A Magni P P Cella M M
CPT: pharmacometrics & systems pharmacology 20160601 6
Alternative designs can increase the feasibility of pediatric trials when compared to classical parallel designs (PaD). In this work we present a model-based approach based on clinical trial simulations for the comparison of PaD with the alternative sequential, crossover, and randomized withdrawal (RWD) designs. Study designs were evaluated in terms of: type I and II errors, sample size per arm (SS), trial duration (TD), treatment exposures, and parameter estimate precision (EP). The crossover r ...[more]
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