Title

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

Year of Publication

2012

Number of Pages

1547-54

Date Published

2012 Mar 15

ISSN Number

1078-0432

Abstract

<p>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.</p>

DOI

10.1158/1078-0432.CCR-11-2205

Alternate Title

Clin. Cancer Res.

PMID

22422407

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