Literature DB >> 24795786

Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models.

Brian P Hobbs1, Daniel J Sargent2, Bradley P Carlin3.   

Abstract

Assessing between-study variability in the context of conventional random-effects meta-analysis is notoriously difficult when incorporating data from only a small number of historical studies. In order to borrow strength, historical and current data are often assumed to be fully homogeneous, but this can have drastic consequences for power and Type I error if the historical information is biased. In this paper, we propose empirical and fully Bayesian modifications of the commensurate prior model (Hobbs et al., 2011) extending Pocock (1976), and evaluate their frequentist and Bayesian properties for incorporating patient-level historical data using general and generalized linear mixed regression models. Our proposed commensurate prior models lead to preposterior admissible estimators that facilitate alternative bias-variance trade-offs than those offered by pre-existing methodologies for incorporating historical data from a small number of historical studies. We also provide a sample analysis of a colon cancer trial comparing time-to-disease progression using a Weibull regression model.

Entities:  

Keywords:  Bayesian analysis; clinical trials; correlated data; historical controls; meta-analysis; survival analysis

Year:  2012        PMID: 24795786      PMCID: PMC4007051          DOI: 10.1214/12-BA722

Source DB:  PubMed          Journal:  Bayesian Anal        ISSN: 1931-6690            Impact factor:   3.728


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3.  Summarizing historical information on controls in clinical trials.

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Review 4.  The combination of randomized and historical controls in clinical trials.

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Authors:  Richard M Goldberg; Daniel J Sargent; Roscoe F Morton; Charles S Fuchs; Ramesh K Ramanathan; Stephen K Williamson; Brian P Findlay; Henry C Pitot; Steven R Alberts
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  9 in total
  33 in total

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2.  Combining Non-randomized and Randomized Data in Clinical Trials Using Commensurate Priors.

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Review 9.  Use of historical control data for assessing treatment effects in clinical trials.

Authors:  Kert Viele; Scott Berry; Beat Neuenschwander; Billy Amzal; Fang Chen; Nathan Enas; Brian Hobbs; Joseph G Ibrahim; Nelson Kinnersley; Stacy Lindborg; Sandrine Micallef; Satrajit Roychoudhury; Laura Thompson
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10.  Adaptive adjustment of the randomization ratio using historical control data.

Authors:  Brian P Hobbs; Bradley P Carlin; Daniel J Sargent
Journal:  Clin Trials       Date:  2013       Impact factor: 2.486

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