ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.
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 8 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
8 citing papers in PubMed, 15 citations in OpenAlex.
- 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
- Comparing Analytic Methods for Longitudinal GWAS and a Case-Study Evaluating Chemotherapy Course Length in Pediatric AML. A Report from the Children's Oncology Group.Frontiers in genetics · 2016Article
- Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.Virchows Archiv : an international journal of pathology · 2014Review
- 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
- 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
- Development and use of integral assays in clinical trials.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
- 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
5 authors at 4 institutions in 1 country.
Funding
Abstract
The U.S. Food and Drug Administration is now exerting its regulatory authority over the use of molecular diagnostics and related assays for medical decision making in clinical trials, by performing pre-Investigational Device Exemption reviews in all phases of clinical trials. In this review, we assess the analytical performance of the assay for the diagnostic, and consider how that performance affects the diagnostic and the patient and their risks and benefits from treatment. We also discuss the process involved in the first review of a new Children's Oncology Group phase III trial in acute myelogenous leukemia. The lessons learned and recommendations for how to prepare for and incorporate this new level of regulatory review into the protocol development process are presented.
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.