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

TitleLessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.
Publication TypeJournal Article
Year of Publication2012
AuthorsMeshinchi S, Hunger SP, Aplenc R, Adamson PC, Jessup JM
JournalClin Cancer Res
Volume18
Issue6
Pagination1547-54
Date Published2012 Mar 15
ISSN1078-0432
KeywordsBiomarkers, Tumor, Clinical Trials, Phase III as Topic, Device Approval, Government Regulation, Humans, Leukemia, Myeloid, Acute, Molecular Diagnostic Techniques, Randomized Controlled Trials as Topic, United States, United States Food and Drug Administration, Validation Studies as Topic
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.

DOI10.1158/1078-0432.CCR-11-2205
Alternate JournalClin. Cancer Res.
PubMed ID22422407
PubMed Central IDPMC3310885
Grant ListU10 CA098543 / CA / NCI NIH HHS / United States
Z99 CA999999 / / Intramural NIH HHS / United States