Compliance with Good Clinical Practice in oncology registration trials in Japan.
Ann Oncol
; 22(6): 1451-1456, 2011 Jun.
Article
en En
| MEDLINE
| ID: mdl-21119030
ABSTRACT
BACKGROUND:
This study aimed to examine the quality in oncology registration trials for new drug application (NDA) or supplemental new drug application (sNDA) as extensions of the indications for use in Japan based on Good Clinical Practice (GCP) audit findings. MATERIALS ANDMETHODS:
We collected audit reports of on-site GCP inspections for registration trials in 383 NDAs or sNDAs that were reviewed by the Pharmaceuticals and Medical Devices Agency between the fiscal years 2004 and 2009.RESULTS:
Among the 40 audits for oncology drug applications, the frequencies at which one or more deficiencies ascribed to institution, investigator, sponsor, and institutional review board were found to be 15 (37.5%), 13 (32.5%), 21 (52.5%), and 10 (25.0%), respectively. The exclusion of patients from the review objective due to serious violations of GCP in 40 audits for oncology drug applications was observed in 2 (5.0%) cases, whereas that in the remaining 343 audits for other drug applications was observed in 40 (11.7%) cases.CONCLUSION:
The overall compliance of GCP in oncology registration trials was moderately better than that in registration trials for other diseases, although there was no statistically significant difference between them.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Aprobación de Drogas
/
Comités de Monitoreo de Datos de Ensayos Clínicos
/
Neoplasias
Límite:
Humans
País/Región como asunto:
Asia
Idioma:
En
Año:
2011
Tipo del documento:
Article