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Title: | A Poisson approach to the validation of failure time surrogate endpoints in individual patient data meta-analyses | Authors: | Rotolo, Federico PAOLETTI, Xavier BURZYKOWSKI, Tomasz BUYSE, Marc Michiels, Stefan |
Issue Date: | 2019 | Publisher: | SAGE PUBLICATIONS LTD | Source: | STATISTICAL METHODS IN MEDICAL RESEARCH, 28(1), p. 170-183 | Abstract: | Surrogate endpoints are often used in clinical trials instead of well-established hard endpoints for practical convenience. The meta-analytic approach relies on two measures of surrogacy: one at the individual level and one at the trial level. In the survival data setting, a two-step model based on copulas is commonly used. We present a new approach which employs a bivariate survival model with an individual random effect shared between the two endpoints and correlated treatment-by-trial interactions. We fit this model using auxiliary mixed Poisson models. We study via simulations the operating characteristics of this mixed Poisson approach as compared to the two-step copula approach. We illustrate the application of the methods on two individual patient data meta-analyses in gastric cancer, in the advanced setting (4069 patients from 20 randomized trials) and in the adjuvant setting (3288 patients from 14 randomized trials). | Notes: | [Rotolo, Federico; Paoletti, Xavier; Michiels, Stefan] Univ Paris Saclay, Inst Gustave Roussy, Serv Biostat & Epidemiol, Villejuif, France. [Rotolo, Federico; Paoletti, Xavier; Michiels, Stefan] Univ Paris Sud, Univ Paris Saclay, INSERM, CESP,UVSQ, Villejuif, France. [Burzykowski, Tomasz; Buyse, Marc] Univ Hasselt, I BioStat, Diepenbeek, Belgium. [Burzykowski, Tomasz; Buyse, Marc] Int Inst Drug Dev, Louvain La Neuve, Belgium.The authors thank the GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group for permission to use their data. The investigators who contributed to GASTRIC are listed in references [16, 17, 38, and 39]. The GASTRIC Group data are available within the surrosurv package for research purposes, under the conditions that (1) the research be scientifically appropriate, (2) the confidentiality of individual patient data be protected, (3) the results of the analyses be shared with the GASTRIC Group prior to public communication, (4) the source of data be fully acknowledged as above, and (5) resulting data and results be further shared with the research community. | Keywords: | Health Care Sciences & Services; Mathematical & Computational Biology; Medical Informatics; Statistics & Probability;Surrogate endpoint; failure time; meta-analysis; copula; randomized trials | Document URI: | http://hdl.handle.net/1942/29576 | ISSN: | 0962-2802 | e-ISSN: | 1477-0334 | DOI: | 10.1177/0962280217718582 | ISI #: | 000454598800011 | Rights: | The Author(s) 2017 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2020 |
Appears in Collections: | Research publications |
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