A scoping review of thresholds for responder and time-to-event analysis of patient-reported outcomes in breast cancer trials.
Sign Up to like & getrecommendations! Published in 2025 at "British journal of clinical pharmacology"
DOI: 10.1002/bcp.70341
Abstract: Patient-reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time-to-event analyses, which depend on predefined thresholds to determine clinically… read more here.
Keywords: time event; breast cancer; responder time;
Core Concepts in Pharmacoepidemiology: Time‐To‐Event Analysis Approaches in Pharmacoepidemiology
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DOI: 10.1002/pds.5886
Abstract: This article provides an overview of time‐to‐event (TTE) analysis in pharmacoepidemiology. read more here.
Keywords: time; analysis; time event; pharmacoepidemiology ... See more keywords
The Win Ratio Approach in Bayesian Monitoring for Two‐Arm Phase II Clinical Trial Designs With Multiple Time‐To‐Event Endpoints
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DOI: 10.1002/sim.10282
Abstract: To assess the preliminary therapeutic impact of a novel treatment, futility monitoring is commonly employed in Phase II clinical trials to facilitate informed decisions regarding the early termination of trials. Given the rapid evolution in… read more here.
Keywords: event endpoints; time; time event; event ... See more keywords
Nonparametric Path‐Specific Effects on a Survival Outcome Through Multiple Time‐to‐Event Mediators
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DOI: 10.1002/sim.10327
Abstract: A causal mediation model with multiple time‐to‐event mediators is exemplified by the natural course of human disease marked by sequential milestones with a time‐to‐event nature. For example, from hepatitis B infection to death, patients may… read more here.
Keywords: event mediators; path specific; time event; event ... See more keywords
A Comparison of Statistical Methods for Time‐To‐Event Analyses in Randomized Controlled Trials Under Non‐Proportional Hazards
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DOI: 10.1002/sim.70019
Abstract: While well‐established methods for time‐to‐event data are available when the proportional hazards assumption holds, there is no consensus on the best inferential approach under non‐proportional hazards (NPH). However, a wide range of parametric and non‐parametric… read more here.
Keywords: non proportional; proportional hazards; methods time; time event ... See more keywords
Adaptive Weight Selection for Time‐To‐Event Data Under Non‐Proportional Hazards
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DOI: 10.1002/sim.70045
Abstract: When planning a clinical trial for a time‐to‐event endpoint, we require an estimated effect size and need to consider the type of effect. Usually, an effect of proportional hazards is assumed with the hazard ratio… read more here.
Keywords: time event; proportional hazards; stage; effect ... See more keywords
Dynamic predictions using flexible joint models of longitudinal and time‐to‐event data
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DOI: 10.1002/sim.7209
Abstract: Joint models for longitudinal and time‐to‐event data are particularly relevant to many clinical studies where longitudinal biomarkers could be highly associated with a time‐to‐event outcome. A cutting‐edge research direction in this area is dynamic predictions… read more here.
Keywords: medicine; longitudinal time; dynamic predictions; time event ... See more keywords
Sizing clinical trials when comparing bivariate time-to-event outcomes.
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DOI: 10.1002/sim.7225
Abstract: Clinical trials with multiple primary time-to-event outcomes are common. Use of multiple endpoints creates challenges in the evaluation of power and the calculation of sample size during trial design particularly for time-to-event outcomes. We present… read more here.
Keywords: time event; clinical trials; event; bivariate ... See more keywords
Bayesian leveraging of historical control data for a clinical trial with time-to-event endpoint.
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DOI: 10.1002/sim.8456
Abstract: The recent 21st Century Cures Act propagates innovations to accelerate the discovery, development, and delivery of 21st century cures. It includes the broader application of Bayesian statistics and the use of evidence from clinical expertise.… read more here.
Keywords: historical data; trial; time event; leveraging historical ... See more keywords
Raking and regression calibration: Methods to address bias from correlated covariate and time-to-event error.
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DOI: 10.1002/sim.8793
Abstract: Medical studies that depend on electronic health records (EHR) data are often subject to measurement error, as the data are not collected to support research questions under study. These data errors, if not accounted for… read more here.
Keywords: methodology; regression; error; time ... See more keywords
A comparison of estimation methods adjusting for selection bias in adaptive enrichment designs with time‐to‐event endpoints
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DOI: 10.1002/sim.9327
Abstract: Adaptive enrichment designs in clinical trials have been developed to enhance drug developments. They permit, at interim analyses during the trial, to select the sub‐populations that benefits the most from the treatment. Because of this… read more here.
Keywords: estimation; time event; selection; estimator ... See more keywords