ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Bridging the gap: moving predictive and prognostic assays from research to clinical use.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 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
20 citing papers in PubMed.
- Comprehensive Liquid Biopsy Approaches for the Clinical Management of Lung Cancer Using Multiple Biological Matrices.International journal of molecular sciences · 2025Review
- Cancer Biomarkers and Precision Oncology: A Review of Recent Trends and Innovations.Clinical Medicine Insights. Oncology · 2024Review
- Adalimumab Immunogenicity Is Negatively Correlated with Anti-Hinge Antibody Levels in Patients with Rheumatoid Arthritis.The Journal of pharmacology and experimental therapeutics · 2020Article
- Prognostic Gene Expression Profiling in Cutaneous Melanoma: Identifying the Knowledge Gaps and Assessing the Clinical Benefit.JAMA dermatology · 2020Review
- Individualized survival prediction for patients with oropharyngeal cancer in the human papillomavirus era.Cancer · 2019Article
- The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications.Cost effectiveness and resource allocation : C/E · 2018Article
- Barrett's oesophagus: Current controversies.World journal of gastroenterology · 2017Review
- Drug Discovery Testing Compounds in Patient Samples by Automated Flow Cytometry.SLAS technology · 2017Article
- A novel quantitative immunohistochemistry method for precise protein measurements directly in formalin-fixed, paraffin-embedded specimens: analytical performance measuring HER2.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2017Article
- Development and validation of a Luminex assay for detection of a predictive biomarker for PROSTVAC-VF therapy.PloS one · 2017Article
- Designing biomarker studies for head and neck cancer.Head & neck · 2014Review
- Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.Virchows Archiv : an international journal of pathology · 2014Review
- Prostate-specific antigen screening in prostate cancer: perspectives on the evidence.Journal of the National Cancer Institute · 2014Article
- Biomarker enrichment strategies: matching trial design to biomarker credentials.Nature reviews. Clinical oncology · 2014Review
- Predictive biomarkers for Barrett's esophagus: so near and yet so far.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2013Review
- From targets to targeted therapies and molecular profiling in non-small cell lung carcinoma.Annals of oncology : official journal of the European Society for Medical Oncology · 2013Review
- Actionable gene expression-based patient stratification for molecular targeted therapy in hepatocellular carcinoma.PloS one · 2013Article
- Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Development and use of integral assays in clinical trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
The development of clinically useful molecular diagnostics requires validation of clinical assay performance and achievement of clinical qualification in clinical trials. As discussed elsewhere in this Focus section on molecular diagnostics, validation of assay performance must be rigorous, especially when the assay will be used to guide treatment decisions. Here we review some of the problems associated with assay development, especially for academic investigators. These include lack of expertise and resources for analytical validation, lack of experience in designing projects for a specific clinical use, lack of specimens from appropriate patient groups, and lack of access to Clinical Laboratory Improvement Amendments-certified laboratories. In addition, financial support for assay validation has lagged behind financial support for marker discovery or drug development, even though the molecular diagnostic may be considered necessary for the successful use of the companion therapeutic. The National Cancer Institute supports a large number of clinical trials and a significant effort in drug development. In order to address some of these barriers for predictive and prognostic assays that will be used in clinical trials to select patients for a particular treatment, stratify patients into molecularly defined subgroups, or choose between treatments for molecularly defined tumors, the National Cancer Institute has begun a pilot program designed to lessen barriers to the development of validated prognostic and predictive assays.
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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.