title: Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.
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.
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Soheil
authors.initials: S
authors.lastname: Meshinchi
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Hunger
authors.forename: Richard
authors.initials: R
authors.lastname: Aplenc
authors.forename: Peter C
authors.initials: PC
authors.lastname: Adamson
authors.forename: J Milburn
authors.initials: JM
authors.lastname: Jessup
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis; D017326:Clinical Trials, Phase III as Topic; D018795:Device Approval; D033161:Government Regulation; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000188:drug therapy; D025202:Molecular Diagnostic Techniques; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic
chemical_list: D014408:Biomarkers, Tumor