ArticleBiostatistics (Oxford, England)2014
Evaluating principal surrogate endpoints with time-to-event data accounting for time-varying treatment efficacy.
Article in Biostatistics (Oxford, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Long-acting insulin analogues for type 1 diabetes: An overview of systematic reviews and meta-analysis of randomized controlled trials.PloS one · 2018Pooled it
- Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve.The Journal of infectious diseases · 2014Trial
- Surrogate Marker Evaluation: A Tutorial Using R.Statistics in medicine · 2025Article
- Surrogacy validation for time-to-event outcomes with illness-death frailty models.Biometrical journal. Biometrische Zeitschrift · 2024Article
- SENSITIVITY ANALYSIS FOR EVALUATING PRINCIPAL SURROGATE ENDPOINTS RELAXING THE EQUAL EARLY CLINICAL RISK ASSUMPTION.The annals of applied statistics · 2022Article
- Robust methods to correct for measurement error when evaluating a surrogate marker.Biometrics · 2022Article
- Evaluation of Surrogate Endpoints Using Information-Theoretic Measure of Association Based on Havrda and Charvat Entropy.Mathematics (Basel, Switzerland) · 2022Article
- Inference on treatment effect modification by biomarker response in a three-phase sampling design.Biostatistics (Oxford, England) · 2020Article
- Predictive cluster level surrogacy in the presence of interference.Biostatistics (Oxford, England) · 2020Article
- Using a surrogate marker for early testing of a treatment effect.Biometrics · 2019Article
- Likelihood-Based Methods for Assessing Principal Surrogate Endpoints in Vaccine Trials.Statistics in biosciences · 2019Article
- Simultaneous Inference of Treatment Effect Modification by Intermediate Response Endpoint Principal Strata with Application to Vaccine Trials.The international journal of biostatistics · 2019Article
- Evaluation and comparison of predictive individual-level general surrogates.Biostatistics (Oxford, England) · 2018Article
- Evaluating principal surrogate markers in vaccine trials in the presence of multiphase sampling.Biometrics · 2018Article
- Evaluating surrogate marker information using censored data.Statistics in medicine · 2017Article
- Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.Statistical communications in infectious diseases · 2017Article
- An Introduction to Principal Surrogate Evaluation with the pseval Package.The R journal · 2016Article
- Predicting Overall Vaccine Efficacy in a New Setting by Re-Calibrating Baseline Covariate and Intermediate Response Endpoint Effect Modifiers of Type-Specific Vaccine Efficacy.Epidemiologic methods · 2016Article
- Power/sample size calculations for assessing correlates of risk in clinical efficacy trials.Statistics in medicine · 2016Article
- Augmented trial designs for evaluation of principal surrogates.Biostatistics (Oxford, England) · 2016Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
Principal surrogate (PS) endpoints are relatively inexpensive and easy to measure study outcomes that can be used to reliably predict treatment effects on clinical endpoints of interest. Few statistical methods for assessing the validity of potential PSs utilize time-to-event clinical endpoint information and to our knowledge none allow for the characterization of time-varying treatment effects. We introduce the time-dependent and surrogate-dependent treatment efficacy curve, ${\mathrm {TE}}(t|s)$, and a new augmented trial design for assessing the quality of a biomarker as a PS. We propose a novel Weibull model and an estimated maximum likelihood method for estimation of the ${\mathrm {TE}}(t|s)$ curve. We describe the operating characteristics of our methods via simulations. We analyze data from the Diabetes Control and Complications Trial, in which we find evidence of a biomarker with value as a PS.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.