ReviewClinical cancer research : an official journal of the American Association for Cancer Research2008
Validation of analytic methods for biomarkers used in drug development.
Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 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
92 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The efficacy of novel biomarkers for the early detection and management of acute kidney injury: A systematic review.PloS one · 2025Pooled it
- A meta-analysis of CXCL12 expression for cancer prognosis.British journal of cancer · 2017Pooled it
- Molecular classifiers for acute kidney transplant rejection in peripheral blood by whole genome gene expression profiling.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2014Trial
- Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways.Clinical pharmacology and therapeutics · 2026Review
- Mass Spectrometry-Based Chromatographic and Computational Workflows for Biomarker and Therapeutic Target Discovery: A Comprehensive Review.Biomedical chromatography : BMC · 2026Review
- Article
- Receptor-Mitochondria Crosstalk in the Kynurenine Metabolic Pathway: Integrating Metabolomics and Clinical Mass Spectrometry.Antioxidants (Basel, Switzerland) · 2026Review
- From skin aging biomarkers to precision esthetic longevity: a translational diagnostic framework.Frontiers in medicine · 2026Article
- Metabolomics: Fundamentals, Methods, Analysis, Limits, and Recommendations.Advances in experimental medicine and biology · 2026Review
- Validation of CXCL9 as a biomarker of morphoea disease state and severity through longitudinal analysis.The British journal of dermatology · 2025Article
- Indirect clinical validation for predictive biomarkers in oncology: International Quality Network for Pathology (IQN Path) Position Paper.Virchows Archiv : an international journal of pathology · 2025Review
- Review
- Recommendations on biomarker assay validation (BAV) in tissues by GCC.Bioanalysis · 2025Article
- Phospholipase D2: A biomarker for stratifying disease severity in acute pancreatitis?World journal of gastroenterology · 2025Article
- Polymerase Chain Reaction Chips for Biomarker Discovery and Validation in Drug Development.Micromachines · 2025Review
- Current Trends in the Biomarker's Discovery for the Treatment and Management of Colorectal Cancer: A Comprehensive Review.Current medicinal chemistry · 2025Review
- Revisiting the Role of B-RAF Kinase as a Therapeutic Target in Melanoma.Current medicinal chemistry · 2024Article
- Biomarkers as Biomedical Bioindicators: Approaches and Techniques for the Detection, Analysis, and Validation of Novel Biomarkers of Diseases.Pharmaceutics · 2023Review
- Characterization of human induced pluripotent stems cells: Current approaches, challenges, and future solutions.Biotechnology reports (Amsterdam, Netherlands) · 2023Review
- Pharmacogenetics of Anticancer Drugs: Clinical Response and Toxicity.Cancer treatment and research · 2023Article
32 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
4 authors.
Funding
Abstract
The role of biomarkers in drug discovery and development has gained precedence over the years. As biomarkers become integrated into drug development and clinical trials, quality assurance and, in particular, assay validation become essential with the need to establish standardized guidelines for analytic methods used in biomarker measurements. New biomarkers can revolutionize both the development and use of therapeutics but are contingent on the establishment of a concrete validation process that addresses technology integration and method validation as well as regulatory pathways for efficient biomarker development. This perspective focuses on the general principles of the biomarker validation process with an emphasis on assay validation and the collaborative efforts undertaken by various sectors to promote the standardization of this procedure for efficient biomarker development.
Indexed as
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.