A Bayesian approach for individual-level drug benefit-risk assessment.

dc.contributor.author

Li, Kan

dc.contributor.author

Luo, Sheng

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Yuan, Sammy

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Mt-Isa, Shahrul

dc.date.accessioned

2019-08-01T14:31:05Z

dc.date.available

2019-08-01T14:31:05Z

dc.date.issued

2019-07

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2019-08-01T14:31:04Z

dc.description.abstract

In existing benefit-risk assessment (BRA) methods, benefit and risk criteria are usually identified and defined separately based on aggregated clinical data and therefore ignore the individual-level differences as well as the association among the criteria. We proposed a Bayesian multicriteria decision-making method for BRA of drugs using individual-level data. We used a multidimensional latent trait model to account for the heterogeneity of treatment effects with latent variables introducing the dependencies among outcomes. We then applied the stochastic multicriteria acceptability analysis approach for BRA incorporating imprecise and heterogeneous patient preference information. We adopted an efficient Markov chain Monte Carlo algorithm when implementing the proposed method. We applied our method to a case study to illustrate how individual-level benefit-risk profiles could inform decision-making.

dc.identifier.issn

0277-6715

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1097-0258

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https://hdl.handle.net/10161/19136

dc.language

eng

dc.publisher

Wiley

dc.relation.ispartof

Statistics in medicine

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10.1002/sim.8166

dc.subject

MCMC

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SMAA

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latent trait model

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patient centered approach

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A Bayesian approach for individual-level drug benefit-risk assessment.

dc.type

Journal article

duke.contributor.orcid

Luo, Sheng|0000-0003-4214-5809

pubs.begin-page

3040

pubs.end-page

3052

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16

pubs.organisational-group

School of Medicine

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Duke

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Duke Clinical Research Institute

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Institutes and Centers

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Biostatistics & Bioinformatics

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Basic Science Departments

pubs.publication-status

Published

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38

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