ArticleClinical investigation2011
Design of clinical trials for biomarker research in oncology.
Article in Clinical investigation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review.Journal of biopharmaceutical statistics · 2016Pooled it
- The Molecular Basis and Biomarker Potential of the HIF-1α-VEGF-GLUT1 Hypoxia Axis in Laryngeal Squamous Cell Carcinoma.Biomedicines · 2026Review
- Using circulating tumor DNA as a novel biomarker of efficacy for dose-finding designs in oncology.Statistical methods in medical research · 2025Article
- Looking ahead in early-phase trial design to improve the drug development process: examples in oncology.BMC medical research methodology · 2023Article
- Evolving notions on immune response in colorectal cancer and their implications for biomarker development.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2018Review
- Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.Journal of personalized medicine · 2017Review
- Bayesian Two-stage Biomarker-based Adaptive Design for Targeted Therapy Development.Statistics in biosciences · 2016Article
- Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.PloS one · 2016Review
- Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity.Molecular oncology · 2015Review
- A review of phase II trial designs for initial marker validation.Contemporary clinical trials · 2013Review
- Mast cells as a potential prognostic marker in prostate cancer.Disease markers · 2013Review
- Article
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 developmental pathway from discovery to clinical practice for biomarkers and biomarker-directed therapies is complex. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence) and the biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay. This review focuses on trial designs for marker validation, both in the setting of early phase trials for initial validation, as well as in the context of larger definitive trials. Designs for biomarker validation are broadly classified as retrospective (i.e., using data from previously well-conducted, randomized, controlled trials) or prospective (enrichment, allcomers or adaptive). We believe that the systematic evaluation and implementation of these design strategies are essential to accelerate the clinical validation of biomarker-guided therapy, thereby taking us a step closer to the goal of personalized medicine.
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.