Multi-objective optimal designs in comparative clinical trials with covariates: the reinforced doubly adaptive biased coin design

DOI10.1214/12-AOS1007MaRDI QIDQ693725zbMATH OpenOpenAlexFDO

Authors Alessandro Baldi Antognini, Maroussa Zagoraiou

Publication date 10 December 2012

Published in The Annals of Statistics (Search for Journal in Brave)

Full work available at URL https://arxiv.org/abs/1206.0576, https://projecteuclid.org/euclid.aos/1344610585

zbMATH Keywords

ethicsinformation criteriabalanceCARA designs

Mathematics Subject Classification ID

Asymptotic properties of nonparametric inference (62G20) Applications of statistics to biology and medical sciences; meta analysis (62P10) Optimal statistical designs (62K05) Sequential statistical design (62L05)

Abstract: The present paper deals with the problem of allocating patients to two competing treatments in the presence of covariates or prognostic factors in order to achieve a good trade-off among ethical concerns, inferential precision and randomness in the treatment allocations. In particular we suggest a multipurpose design methodology that combines efficiency and ethical gain when the linear homoscedastic model with both treatment/covariate interactions and interactions among covariates is adopted. The ensuing compound optimal allocations of the treatments depend on the covariates and their distribution on the population of interest, as well as on the unknown parameters of the model. Therefore, we introduce the reinforced doubly adaptive biased coin design, namely a general class of covariate-adjusted response-adaptive procedures that includes both continuous and discontinuous randomization functions, aimed to target any desired allocation proportion. The properties of this proposal are described both theoretically and through simulations.

Recommendations

• The covariate-adaptive biased coin design for balancing clinical trials in the presence of prognostic factors
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• Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trials.
• Some recent developments in the design of adaptive clinical trials

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Cited in

(13)

• Corrigendum to: ``On recent advances in optimal allocation designs in clinical trials
• Nonparametric covariate-adjusted response-adaptive design based on a functional urn model
• Doubly adaptive biased coin designs for balancing competing objectives in time-to-event trials
• Multi-objective optimal designs in comparative clinical trials with covariates: the reinforced doubly adaptive biased coin design
• Optimal response and covariate-adaptive biased-coin designs for clinical trials with continuous multivariate or longitudinal responses
• Covariate-adaptive optimization in online clinical trials
• Multiple-objective optimal designs for studying the dose response function and interesting dose levels
• The covariate-adaptive biased coin design for balancing clinical trials in the presence of prognostic factors
• Robust design in a two treatment comparison in the presence of a covariate
• On the almost sure convergence of adaptive allocation procedures
• The Efficient Covariate-Adaptive Design for high-order balancing of quantitative and qualitative covariates
• General covariate-adaptive randomization targeting unequal allocation ratio
• Response-adaptive randomization in clinical trials: from myths to practical considerations

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