| Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031. | |
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MedLine Citation:
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PMID: 22422407 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Soheil Meshinchi; Stephen P Hunger; Richard Aplenc; Peter C Adamson; J Milburn Jessup |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical cancer research : an official journal of the American Association for Cancer Research Volume: 18 ISSN: 1078-0432 ISO Abbreviation: Clin. Cancer Res. Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-03-16 Completed Date: 2012-06-28 Revised Date: 2013-04-16 |
Medline Journal Info:
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Nlm Unique ID: 9502500 Medline TA: Clin Cancer Res Country: United States |
Other Details:
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Languages: eng Pagination: 1547-54 Citation Subset: IM |
Affiliation:
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Fred Hutchinson Cancer Research Center, Seattle, WA, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials, Phase III as Topic Device Approval* Government Regulation* Humans Leukemia, Myeloid, Acute / diagnosis, drug therapy Molecular Diagnostic Techniques* Randomized Controlled Trials as Topic Tumor Markers, Biological / analysis United States United States Food and Drug Administration* Validation Studies as Topic |
| Grant Support | |
ID/Acronym/Agency:
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Z99 CA999999/CA/NCI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Tumor Markers, Biological |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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