Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.
Clin Cancer Res
; 18(6): 1547-54, 2012 Mar 15.
Article
en En
| MEDLINE
| ID: mdl-22422407
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.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
United States Food and Drug Administration
/
Aprobación de Recursos
/
Técnicas de Diagnóstico Molecular
/
Regulación Gubernamental
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Guideline
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Prognostic_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Clin Cancer Res
Asunto de la revista:
NEOPLASIAS
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos