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Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process

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Version 2 2024-03-26, 17:11
Version 1 2015-10-21, 10:18
journal contribution
posted on 2024-03-26, 17:11 authored by Sylwia Bujkiewicz, John R. Thompson, R. D. Riley, Keith R. Abrams
A number of meta-analytical methods have been proposed that aim to evaluate surrogate endpoints. Bivariate meta-analytical methods can be used to predict the treatment effect for the final outcome from the treatment effect estimate measured on the surrogate endpoint while taking into account the uncertainty around the effect estimate for the surrogate endpoint. In this paper, extensions to multivariate models are developed aiming to include multiple surrogate endpoints with the potential benefit of reducing the uncertainty when making predictions. In this Bayesian multivariate meta-analytic framework, the between-study variability is modelled in a formulation of a product of normal univariate distributions. This formulation is particularly convenient for including multiple surrogate endpoints and flexible for modelling the outcomes which can be surrogate endpoints to the final outcome and potentially to one another. Two models are proposed, first using an unstructured between-study covariance matrix by assuming the treatment effects on all outcomes are correlated and second using a structured between- study covariance matrix by assuming treatment effects on some of the outcomes are conditionally independent. While the two models are developed for the summary data on a study level, the individual-level association is taken into account by the use of the Prentice’s criteria (obtained from individual patient data) to inform the within study correlations in the models. The modelling techniques are investigated using an example in relapsing remitting multiple sclerosis where the disability worsening is the final outcome, while relapse rate and MRI lesions are potential surrogates to the disability progression.

History

Citation

Statistics in Medicine, 2016, 35 (7), pp. 1063-1089

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Health Sciences

Version

  • VoR (Version of Record)

Published in

Statistics in Medicine

Volume

35

Issue

7

Pagination

1063-1089

Publisher

Wiley

issn

0277-6715

eissn

1097-0258

Copyright date

2015

Available date

2016-04-07

Notes

Correction to: Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process (Statistics in Medicine, (2016), 35, 7, (1063-1089), 10.1002/sim.6776) Correction: https://doi.org/10.1002/sim.9597 I would like to report an erratum to the paper titled 'Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process' by Bujkiewicz, Thompson, Riley and Abrams, Statistics in Medicine

Language

en

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