ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Development and use of integral assays in clinical trials.
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.
- Analytical Validation and Application of a Targeted Next-Generation Sequencing Mutation-Detection Assay for Use in Treatment Assignment in the NCI-MPACT Trial.The Journal of molecular diagnostics : JMD · 2016Trial
- Unraveling Nature's Pharmacy: Transforming Medicinal Plants into Modern Therapeutic Agents.Pharmaceutics · 2025Review
- Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker.The AAPS journal · 2020Review
- Prognostic Gene Expression Profiling in Cutaneous Melanoma: Identifying the Knowledge Gaps and Assessing the Clinical Benefit.JAMA dermatology · 2020Review
- The endless frontier? The recent increase of R&D productivity in pharmaceuticals.Journal of translational medicine · 2020Article
- Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.Clinical pharmacology and therapeutics · 2020Article
- Whole-Exome Sequencing and Whole-Genome Sequencing in Critically Ill Neonates Suspected to Have Single-Gene Disorders.Cold Spring Harbor perspectives in medicine · 2015Review
- Biomarker development in the context of urologic cancers.Urologic oncology · 2015Review
- Current status of molecular biomarkers in endometrial cancer.Current oncology reports · 2014Review
- Molecular biomarkers for grass pollen immunotherapy.World journal of methodology · 2014Review
- Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.BMC medicine · 2013Article
- Validation and clinical utility of prostate cancer biomarkers.Nature reviews. Clinical oncology · 2013Review
- Publicly funded clinical trials and the future of cancer care.The oncologist · 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
- 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
4 authors.
Funding
Abstract
Clinical trials that include integral biomarkers to determine eligibility, assign treatment, or assess outcome must employ robust assays to measure the molecular analyte of interest. The decision to develop a biomarker assay into a test suitable for use in humans should be driven by clinical need, that is, there should be a clear clinical purpose for undertaking the test development. Supporting in vitro or in vivo research on the ability of the marker to distinguish subgroups of patients with a given characteristic is necessary. The magnitude of the difference in treatment effect expected with use of the marker should be sufficient to support differential treatment prescription for marker-positive and -negative patients. Analytical and clinical validation of the marker assay should be completed before the clinical trial is initiated to ensure that the assay is stable enough for clinical use throughout the trial. Clinical use of the assay requires that it be performed in a Clinical Laboratory Improvement Amendments-accredited laboratory, and the need to apply for an Investigational Device Exemption from the U.S. Food and Drug Administration should be considered. In this article we elaborate on the steps required to get a biomarker assay ready for use as an integral component of a clinical trial and give an example of the use of an integral assay in a phase III trial.
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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.