Document Detail

Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.
MedLine Citation:
PMID:  22422407     Owner:  NLM     Status:  MEDLINE    
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.
Soheil Meshinchi; Stephen P Hunger; Richard Aplenc; Peter C Adamson; J Milburn Jessup
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Publication Detail:
Type:  Journal Article    
Journal Detail:
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:
Created Date:  2012-03-16     Completed Date:  2012-06-28     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  9502500     Medline TA:  Clin Cancer Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1547-54     Citation Subset:  IM    
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
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MeSH Terms
Clinical Trials, Phase III as Topic
Device Approval*
Government Regulation*
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
Reg. No./Substance:
0/Tumor Markers, Biological

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