ArticleStatistics in biopharmaceutical research2021
Statistical models for composite endpoints of death and non-fatal events: a review.
Article in Statistics in biopharmaceutical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Generalizing the Finkelstein-Schoenfeld Test to Incorporate Multiple Alternating Thresholds.Biometrical journal. Biometrische Zeitschrift · 2026Article
- Composite endpoints in health technology assessment: Part 1 - an illustration of best modeling practice.Journal of comparative effectiveness research · 2025Article
- Specification of Estimands for Complex Disease Processes Using Multistate Models and Utility Functions.Statistics in medicine · 2025Article
- Exploring Causal Effects of Hormone- and Radio-Treatments in an Observational Study of Breast Cancer Using Copula-Based Semi-Competing Risks Models.Statistics in medicine · 2025Article
- The Win Ratio Approach in Bayesian Monitoring for Two-Arm Phase II Clinical Trial Designs With Multiple Time-To-Event Endpoints.Statistics in medicine · 2024Article
- Multiply robust estimation of principal causal effects with noncompliance and survival outcomes.Clinical trials (London, England) · 2024Article
- Short Course Antibiotic Therapy for Catheter-Related Septic Thrombosis: "Caveat Emptor!": Duration of Therapy Should Not Be SetPathogens (Basel, Switzerland) · 2024Review
- Dissecting the restricted mean time in favor of treatment.Journal of biopharmaceutical statistics · 2024Article
- Adaptive clinical trial designs with blinded selection of binary composite endpoints and sample size reassessment.Biostatistics (Oxford, England) · 2023Article
- Article
- Article
- The Impact of Glucagon-Like Peptide-1 Receptor Agonist on the Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus: A Meta-Analysis and Systematic Review.Cardiology research · 2023Article
- On restricted mean time in favor of treatment.Biometrics · 2023Article
- The empirical estimate of the survival and variance using a weighted composite endpoint.BMC medical research methodology · 2023Article
- Power and Sample Size Calculations for the Restricted Mean Time Analysis of Prioritized Composite Endpoints.Statistics in biopharmaceutical research · 2023Article
- Stratified proportional win-fractions regression analysis.Statistics in medicine · 2022Article
- On recurrent-event win ratio.Statistical methods in medical research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
The proper analysis of composite endpoints consisting of both death and non-fatal events is an intriguing and sometimes contentious topic. The current practice of analyzing time to the first event often draws criticisms for ignoring the unequal importance between component events and for leaving recurrent-event data unused. Novel methods that address these limitations have recently been proposed. To compare the novel versus traditional approaches, we review three typical models for composite endpoints based on time to the first event, composite event process, and pairwise hierarchical comparisons. The pros and cons of these models are discussed with reference to the relevant regulatory guidelines, such as the recently released ICH-E9(R1) Addendum "Estimands and Sensitivity Analysis in Clinical Trials". We also discuss the impact of censoring when the model assumptions are violated and explore sensitivity analysis strategies. Simulation studies are conducted to assess the performance of the reviewed methods under different settings. As demonstration, we use publicly available R-packages to analyze real data from a major cardiovascular trial.
Indexed as
Identifiers
What OpenQuestion holds
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.