ArticleJournal of the National Cancer Institute2015
The Fundamental Difficulty With Evaluating the Accuracy of Biomarkers for Guiding Treatment.
Article in Journal of the National Cancer Institute, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and cost-effectiveness analysis.Health technology assessment (Winchester, England) · 2022Pooled it
- Sample size methods for evaluation of predictive biomarkers.Statistics in medicine · 2022Trial
- Weight loss at your fingertips: personalized nutrition with fasting glucose and insulin using a novel statistical approach.European journal of clinical nutrition · 2019Trial
- Baseline Moderators of Response to Naltrexone and Bupropion in the Treatment of Methamphetamine Use Disorder: An ADAPT-2 Study.Journal of addiction medicineTrial
- Advancing equitable and personalized cancer care: Novel applications and priorities of artificial intelligence for fairness and inclusivity in the patient care workflow.European journal of cancer (Oxford, England : 1990) · 2024Review
- Breast Cancer; Discovery of Novel Diagnostic Biomarkers, Drug Resistance, and Therapeutic Implications.Frontiers in molecular biosciences · 2022Review
- Recent Discoveries of Macromolecule- and Cell-Based Biomarkers and Therapeutic Implications in Breast Cancer.International journal of molecular sciences · 2021Review
- Predictive approaches to heterogeneous treatment effects: a scoping review.BMC medical research methodology · 2020Article
- The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration.Annals of internal medicine · 2020Article
- MGMT promoter methylation status testing to guide therapy for glioblastoma: refining the approach based on emerging evidence and current challenges.Neuro-oncology · 2019Review
- Auxiliary variable-enriched biomarker-stratified design.Statistics in medicine · 2018Article
- Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects.BMJ (Clinical research ed.) · 2018Review
- Clinical trials in gynecologic oncology: Past, present, and future.Gynecologic oncology · 2018Review
- Molecular and Functional Diagnostic Tools in Precision Oncology for Urological Malignancies.Indian journal of surgical oncology · 2017Review
- Evaluating Markers for Guiding Treatment.Journal of the National Cancer Institute · 2016Article
- Confronting the Care Delivery Challenges Arising from Precision Medicine.Frontiers in oncology · 2016Review
- On the quantitative assessment of predictive biomarkers.Journal of the National Cancer Institute · 2015Article
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Authors and funding
5 authors.
Funding
Abstract
Developing biomarkers that can predict whether patients are likely to benefit from an intervention is a pressing objective in many areas of medicine. Recent guidance documents have recommended that the accuracy of predictive biomarkers, ie, sensitivity, specificity, and positive and negative predictive values, should be assessed. We clarify the meanings of these entities for predictive markers and demonstrate that generally they cannot be estimated from data without making strong untestable assumptions. Language suggesting that predictive biomarkers can identify patients who benefit from an intervention is also widespread. We show that in general one cannot estimate the chance that a patient will benefit from treatment. We recommend instead that predictive biomarkers be evaluated with respect to their ability to predict clinical outcomes among patients treated and among patients receiving standard of care, and the population impact of treatment rules based on those predictions. Ideally these entities are estimated from a randomized trial comparing the experimental intervention with standard of care.
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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.