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SelectedWorks

2010

Clinical Trials

Articles 1 - 2 of 2

Full-Text Articles in Life Sciences

Links Between Analysis Of Surrogate Endpoints And Endogeneity, Debashis Ghosh, Jeremy M. Taylor, Michael R. Elliott Jan 2010

Links Between Analysis Of Surrogate Endpoints And Endogeneity, Debashis Ghosh, Jeremy M. Taylor, Michael R. Elliott

Debashis Ghosh

There has been substantive interest in the assessment of surrogate endpoints in medical research. These are measures which could potentially replace \true" endpoints in clinical trials and lead to studies that require less follow-up. Recent research in the area has focused on assessments using causal inference frameworks. Beginning with a simple model for associating the surrogate and true endpoints in the population, we approach the problem as one of endogenous covariates. An instrumental variables estimator and general two-stage algorithm is proposed. Existing surrogacy frameworks are then evaluated in the context of the model. A numerical example is used to illustrate …


Meta-Analysis For Surrogacy: Accelerated Failure Time Models And Semicompeting Risks Modelling, Debashis Ghosh, Jeremy M. Taylor, Daniel J. Sargent Jan 2010

Meta-Analysis For Surrogacy: Accelerated Failure Time Models And Semicompeting Risks Modelling, Debashis Ghosh, Jeremy M. Taylor, Daniel J. Sargent

Debashis Ghosh

There has been great recent interest in the medical and statistical literature in the assessment and validation of surrogate endpoints as proxies for clinical endpoints in medical studies. More recently, authors have focused on using meta-analytical methods for quanti cation of surrogacy. In this article, we extend existing procedures for analysis based on the accelerated failure time model to this setting. An advantage of this approach relative to proportional hazards model is that it allows for analysis in the semi-competing risks setting, where we constrain the surrogate endpoint to occur before the true endpoint. A novel principal components procedure is …