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Combined Estimation of Treatment Effects Under a Discrete Random Effects Model

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Abstract

Combining information from different groups of data, such as regions in a multi-regional study or trials in a meta-analysis, is an increasingly important problem in clinical drug development. This paper focuses on the combination of treatment effect estimates from independent sources of data (e.g., regions, trials) under a discrete, patient-level random effects model. The approach is motivated by multi-regional clinical studies, being also illustrated in the context of meta-analysis. Comparisons to traditional combination of information methods based on fixed effects (multi-regional trials) and study-level random effects (meta-analysis) are also discussed.

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References

  1. Borenstein M, Hedges LV, Higgins JPT, Rothstein HR (2009) Introduction to meta-analysis. Wiley, Chichester

    Book  MATH  Google Scholar 

  2. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177–188

    Article  Google Scholar 

  3. Follmann DA, Proschan MA (1999) Valid inference in random effects meta-analysis. Biometrics 55:732–737

    Article  MATH  Google Scholar 

  4. Hung HMJ, Wang SJ, O’Neill RT (2010) Consideration of regional difference in design and analysis of multi-regional trials. Pharm Stat 9:173–178

    Article  Google Scholar 

  5. Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004) Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 364(9450):2021–2029. doi:10.1016/S0140-6736(04)17514-4

    Article  Google Scholar 

  6. Mukherjee D, Nissen SE, Topol EJ (2001) Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286(8):954–959. doi:10.1001/jama.286.8.954. PMID 11509060

    Article  Google Scholar 

  7. Nissen SE, Wolski K (2007) Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356(24):2457–2471. doi:10.1056/NEJMoa072761. PMID 17517853

    Article  Google Scholar 

  8. Quan H, Li M, Chen J, Gallo P, Binkowitz B, Ibia E, Tanaka Y, Ouyang P, Luo X, Li G (2010) Assessment of consistency of treatment effects in multiregional clinical trials. Drug Inf J 44:617–632

    Article  Google Scholar 

  9. Whitehead A (2002) Meta-analysis of controlled clinical trials. Wiley, Chichester

    Book  Google Scholar 

Download references

Acknowledgement

We would like to thank the Associate Editor and referees for their useful comments and suggestions, which greatly improved the quality and readability of the manuscript.

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  1. Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ, USA

    K. K. Gordon Lan & José Pinheiro

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  1. K. K. Gordon Lan
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  2. José Pinheiro
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Correspondence to José Pinheiro.

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Lan, K.K.G., Pinheiro, J. Combined Estimation of Treatment Effects Under a Discrete Random Effects Model. Stat Biosci 4, 235–244 (2012). https://doi.org/10.1007/s12561-012-9054-9

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  • DOI: https://doi.org/10.1007/s12561-012-9054-9

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