Format

Send to

Choose Destination
Clin Cancer Res. 2012 Mar 15;18(6):1547-54. doi: 10.1158/1078-0432.CCR-11-2205.

Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.

Author information

1
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

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.

PMID:
22422407
PMCID:
PMC3310885
DOI:
10.1158/1078-0432.CCR-11-2205
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for HighWire Icon for PubMed Central
Loading ...
Support Center