ArticleJournal of the National Cancer Institute2013
Statistical and practical considerations for clinical evaluation of predictive biomarkers.
Article in Journal of the National Cancer Institute, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 3 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
76 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- RNA-Binding Protein Polymorphisms as Novel Biomarkers to Predict Outcomes of Metastatic Colorectal Cancer: A Meta-analysis from TRIBE, FIRE-3, and MAVERICC.Molecular cancer therapeutics · 2021Pooled it
- Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Guideline
- Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Guideline
- Re-examining post-operative chemoradiotherapy in head and neck cancer: an updated long-term combined analysis of RTOG 9501/EORTC 22931.Annals of oncology : official journal of the European Society for Medical Oncology · 2025Trial
- Sample size methods for evaluation of predictive biomarkers.Statistics in medicine · 2022Trial
- Prognostic and predictive significance of nuclear HIF1α expression in locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab.British journal of cancer · 2020Trial
- Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Adjusting for covariates in evaluating markers for selecting treatment, with application to guiding chemotherapy for treating estrogen-receptor-positive, node-positive breast cancer.Contemporary clinical trials · 2017Trial
- Prospective Validation of Diagnostic Tumor Biomarkers in Men Treated With Radiotherapy for Prostate Cancer.Journal of the National Cancer Institute · 2017Trial
- Trial
- AMPK Pathway Activation Markers in GBM: Expression Patterns and Clinical Associations in a Real-World Study.International journal of molecular sciences · 2026Article
- Article
- Expert recommendations for PIK3CA testing in HR+/HER2- locally advanced and metastatic breast cancer.NPJ breast cancer · 2026Review
- Multi-omics strategies for biomarker discovery and application in personalized oncology.Molecular biomedicine · 2025Review
- Predicting resistance to chemotherapy using chromosomal instability signatures.Nature genetics · 2025Article
- Case-only analysis in small studies of predictive biomarkers.Scientific reports · 2025Article
- A Novel Approach to Assess the Predictiveness of a Continuous Biomarker in Early Phases of Drug Development.Statistics in medicine · 2025Article
- Strength of evidence underlying the CMS-FDA parallel review of comprehensive genomic profiling tests in the cancer setting.Journal of the National Cancer Institute · 2025Article
- Folate-engineered chitosan nanoparticles: next-generation anticancer nanocarriers.Molecular cancer · 2024Review
16 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Predictive biomarkers to guide therapy for cancer patients are a cornerstone of precision medicine. Discussed herein are considerations regarding the design and interpretation of such predictive biomarker studies. These considerations are important for both planning and interpreting prospective studies and for using specimens collected from completed randomized clinical trials. Specific issues addressed are differentiation between qualitative and quantitative predictive effects, challenges due to sample size requirements for predictive biomarker assessment, and consideration of additional factors relevant to clinical utility assessment, such as toxicity and cost of new therapies as well as costs and potential morbidities associated with routine use of biomarker-based tests.
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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.