Does the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpoints

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dc.authorid0000-0002-8335-1927en_US
dc.contributor.authorSertdemir, Yaşar
dc.contributor.authorBurgut, Hüseyin Refik
dc.date.accessioned2024-07-12T21:03:05Z
dc.date.available2024-07-12T21:03:05Z
dc.date.issued2009en_US
dc.departmentFakülteler, Tıp Fakültesien_US
dc.description.abstractBackground: In recent years the use of surrogate end points (S) has become an interesting issue. In clinical trials, it is important to get treatment outcomes as early as possible. For this reason there is a need for surrogate endpoints (S) which are measured earlier than the true endpoint (T). However, before a surrogate endpoint can be used it must be validated. For a candidate surrogate endpoint, for example time to recurrence, the validation result may change dramatically between clinical trials. The aim of this study is to show how the validation criterion (R(2)(trial)) proposed by Buyse et al. are influenced by the magnitude of treatment effect with an application using real data. Methods: The criterion R(2)(trial) proposed by Buyse et al. (2000) is applied to the four data sets from colon cancer clinical trials (C-01, C-02, C-03 and C-04). Each clinical trial is analyzed separately for treatment effect on survival (true endpoint) and recurrence free survival (surrogate endpoint) and this analysis is done also for each center in each trial. Results are used for standard validation analysis. The centers were grouped by the Wald statistic in 3 equal groups. Results: Validation criteria R(2)(trial) were 0.641 95% CI (0.432-0.782), 0.223 95% CI (0.008-0.503), 0.761 95% CI (0.550-0.872) and 0.560 95% CI (0.404-0.687) for C-01, C-02, C-03 and C-04 respectively. The R(2)(trial) criteria changed by the Wald statistics observed for the centers used in the validation process. Higher the Wald statistic groups are higher the R(2)(trial) values observed. Conclusion: The recurrence free survival is not a good surrogate for overall survival in clinical trials with non significant treatment effects and moderate for significant treatment effects. This shows that the level of significance of treatment effect should be taken into account in validation process of surrogate endpoints.en_US
dc.identifier.citationSertdemir, Y. ve Burgut, H. R. (2009). Does the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpoints. Contemp Clin Trials. 30(1), s. 8-12.en_US
dc.identifier.endpage12en_US
dc.identifier.issue1en_US
dc.identifier.startpage8en_US
dc.identifier.urihttps://pubmed.ncbi.nlm.nih.gov/18809512/
dc.identifier.urihttps://hdl.handle.net/20.500.12415/3628
dc.identifier.volume30en_US
dc.institutionauthorBurgut, Hüseyin Refik
dc.language.isoenen_US
dc.publisherNational Center for Biotechnology Informationen_US
dc.relation.ispartofContemp Clin Trialsen_US
dc.relation.isversionof10.1016/j.cct.2008.08.006en_US
dc.relation.publicationcategoryUluslararası Hakemli Dergide Makale - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.snmzKY00562
dc.subjectSurrogate endpointen_US
dc.subjectValidation criteriaen_US
dc.subjectColon canceren_US
dc.subjectMeta-analyticen_US
dc.subjectClinical trialsen_US
dc.titleDoes the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpointsen_US
dc.typeArticle
dspace.entity.typePublication

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