SynthesisJournal of biopharmaceutical statistics2016
Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review.
Synthesis in Journal of biopharmaceutical statistics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 2 of them syntheses that pooled it.
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
47 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Cost-Effectiveness of Pharmacogenomic and Pharmacogenetic Test-Guided Personalized Therapies: A Systematic Review of the Approved Active Substances for Personalized Medicine in Germany.Advances in therapy · 2016Pooled it
- Weight loss at your fingertips: personalized nutrition with fasting glucose and insulin using a novel statistical approach.European journal of clinical nutrition · 2019Trial
- Personalizing chronotherapy of immune checkpoint blockade.Journal for immunotherapy of cancer · 2025Article
- A Seamless Hybrid Phase II/III Design With Bayesian Interim Subgroup Selection.Statistics in medicine · 2025Article
- A patient similarity-embedded Bayesian approach to prognostic biomarker inference with application to thoracic cancer immunity.Journal of the Royal Statistical Society. Series C, Applied statistics · 2025Article
- Consistency-Based Approach to Adjust for Multiplicity in Confirmatory Subgroup Analysis.Statistics in medicine · 2025Article
- Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency.Clinical pharmacology and therapeutics · 2025Review
- Adaptive enrichment trial designs using joint modelling of longitudinal and time-to-event data.Statistical methods in medical research · 2024Article
- Toward Precision in Critical Care Research: Methods for Observational and Interventional Studies.Critical care medicine · 2024Review
- Using biomarkers to allocate patients in a response-adaptive clinical trial.Communications in statistics: Simulation and computation · 2023Article
- Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial.Clinical trials (London, England) · 2023Article
- AN OMNIBUS TEST FOR DETECTION OF SUBGROUP TREATMENT EFFECTS VIA DATA PARTITIONING.The annals of applied statistics · 2022Article
- The role of baseline serum 25(OH)D concentration for a potential personalized vitamin D supplementation.European journal of clinical nutrition · 2022Article
- Article
- A Bayesian decision-theoretic design for simultaneous biomarker-based subgroup selection and efficacy evaluation.Statistics in biopharmaceutical research · 2022Article
- Article
- Selecting predictive biomarkers from genomic data.PloS one · 2022Article
- Frequentist rules for regulatory approval of subgroups in phase III trials: A fresh look at an old problem.Statistical methods in medical research · 2021Article
- Optimizing subgroup selection in two-stage adaptive enrichment and umbrella designs.Statistics in medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Important objectives in the development of stratified medicines include the identification and confirmation of subgroups of patients with a beneficial treatment effect and a positive benefit-risk balance. We report the results of a literature review on methodological approaches to the design and analysis of clinical trials investigating a potential heterogeneity of treatment effects across subgroups. The identified approaches are classified based on certain characteristics of the proposed trial designs and analysis methods. We distinguish between exploratory and confirmatory subgroup analysis, frequentist, Bayesian and decision-theoretic approaches and, last, fixed-sample, group-sequential, and adaptive designs and illustrate the available trial designs and analysis strategies with published case studies.
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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.