ArticleClinical trials (London, England)2017
Evaluating biomarkers for prognostic enrichment of clinical trials.
Article in Clinical trials (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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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.
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Who cites it
22 citing papers in PubMed.
- Kidney Biomarkers of Injury and Repair as Predictors of Contrast-Associated AKI: A Substudy of the PRESERVE Trial.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2020Trial
- Article
- Beyond Genotype: Multidomain Biomarker-Integrated Risk Scores Reveal Prognostic phenotypes Among Individuals with High-RiskmedRxiv : the preprint server for health sciences · 2026Article
- Evaluating the utility of prognostic enrichment in clinical trials: Applications to clinical trial design in osteoarthritis.Osteoarthritis and cartilage · 2026Article
- Nanomedicine for Acute Respiratory Distress Syndrome: From Pathophysiological Mechanisms and Disease Heterogeneity to Precision Therapy.International journal of nanomedicine · 2026Review
- Biochemical biomarkers of knee osteoarthritis progression: Results from the FNIH biomarkers consortium progress OA study.Osteoarthritis and cartilage open · 2025Article
- Review
- Rationale and Design of a Phase 2, Double-blind, Placebo-Controlled, Randomized Trial Evaluating AMP Kinase-Activation by Metformin in Focal Segmental Glomerulosclerosis.Kidney international reports · 2024Article
- Reducing Sample Size While Improving Equity in Vaccine Clinical Trials: A Machine Learning-Based Recruitment Methodology with Application to Improving Trials of Hepatitis C Virus Vaccines in People Who Inject Drugs.Healthcare (Basel, Switzerland) · 2024Article
- An explainable machine learning-based phenomapping strategy for adaptive predictive enrichment in randomized clinical trials.NPJ digital medicine · 2023Article
- Biomarkers in acute kidney injury: On the cusp of a new era?The Journal of clinical investigation · 2023Article
- More efficient and inclusive time-to-event trials with covariate adjustment: a simulation study.Trials · 2023Article
- Review
- Longitudinal Assessment of Creatine Kinase, Creatine/CreatinineNeurology · 2023Article
- Evaluation of galectin-3 and intestinal fatty acid binding protein as serum biomarkers in autosomal recessive polycystic kidney disease.Journal of nephrology · 2023Article
- Comparison of Circulating Biomarkers in Predicting Diabetic Kidney Disease Progression With Autoantibodies to Erythropoietin Receptor.Kidney international reports · 2021Article
- BioPETsurv: Methodology and open source software to evaluate biomarkers for prognostic enrichment of time-to-event clinical trials.PloS one · 2020Article
- Article
- Acute Respiratory Distress Syndrome Phenotypes.Seminars in respiratory and critical care medicine · 2019Review
- Plasma biomarkers are associated with renal outcomes in individuals with APOL1 risk variants.Kidney international · 2018Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
BACKGROUND/
aimsA potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment.
methodsWe identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency.
resultsWe demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform.
conclusionIn some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.
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