ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development.
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 17 papers.
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, 48 citations in OpenAlex.
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- Medical Applications of Molecular Biotechnologies in the Context of Hashimoto's Thyroiditis.Diagnostics (Basel, Switzerland) · 2023Review
- Clinical Utility of Oncuria™, a Multiplexed Liquid Biopsy for the Non-Invasive Detection of Bladder Cancer-A Pilot Study.Diagnostics (Basel, Switzerland) · 2022Article
- Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.Clinical pharmacology and therapeutics · 2020Article
- Implantation and extravillous trophoblast invasion: From rare archival specimens to modern biobanking.Placenta · 2017Review
- Bayesian Two-stage Biomarker-based Adaptive Design for Targeted Therapy Development.Statistics in biosciences · 2016Article
- uPA and PAI-1 as biomarkers in breast cancer: validated for clinical use in level-of-evidence-1 studies.Breast cancer research : BCR · 2014Review
- Profiling of phospho-AKT, phospho-mTOR, phospho-MAPK and EGFR in non-small cell lung cancer.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2014Article
- Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.Virchows Archiv : an international journal of pathology · 2014Review
- A multiplex two-color real-time PCR method for quality-controlled molecular diagnostic testing of FFPE samples.PloS one · 2014Article
- Recurrence of early stage colon cancer predicted by expression pattern of circulating microRNAs.PloS one · 2014Article
- Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.BMC medicine · 2013Article
- Actionable gene expression-based patient stratification for molecular targeted therapy in hepatocellular carcinoma.PloS one · 2013Article
- Development and use of integral assays in clinical trials.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
- Bridging the gap: moving predictive and prognostic assays from research to clinical use.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Impact of preanalytic factors on the design and application of integral biomarkers for directing patient therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
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 at 3 institutions in 2 countries.
Funding
Abstract
Molecular diagnostics are becoming increasingly important in clinical research to stratify or identify molecularly profiled patient cohorts for targeted therapies, to modify the dose of a therapeutic, and to assess early response to therapy or monitor patients. Molecular diagnostics can also be used to identify the pharmacogenetic risk of adverse drug reactions. The articles in this CCR Focus section on molecular diagnosis describe the development and use of markers to guide medical decisions regarding cancer patients. They define sources of preanalytic variability that need to be minimized, as well as the regulatory and financial challenges involved in developing diagnostics and integrating them into clinical practice. They also outline a National Cancer Institute program to assist diagnostic development. Molecular diagnostic clinical tests require rigor in their development and clinical validation, with sensitivity, specificity, and validity comparable to those required for the development of therapeutics. These diagnostics must be offered at a realistic cost that reflects both their clinical value and the costs associated with their development. When genome-sequencing technologies move into the clinic, they must be integrated with and traceable to current technology because they may identify more efficient and accurate approaches to drug development. In addition, regulators may define progressive drug approval for companion diagnostics that requires further evidence regarding efficacy and safety before full approval can be achieved. One way to accomplish this is to emphasize phase IV postmarketing, hypothesis-driven clinical trials with biological characterization that would permit an accurate definition of the association of low-prevalence gene alterations with toxicity or response in large cohorts.
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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.