Compliance with Good Clinical Practice in oncology registration trials in Japan.
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.


METHODS
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.


CONCLUSIONS
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.
Department of Breast and Medical Oncology, National Cancer Center Hospital. Electronic address: kyonemor@ncc.go.jp.
K
K
Yonemori
Department of Management Science, Graduate School of Engineering, Tokyo University of Science.
A
A
Hirakawa
Department of Breast and Medical Oncology, National Cancer Center Hospital; Department of Clinical Trial Coordination and Developmental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
M
M
Ando
Department of Breast and Medical Oncology, National Cancer Center Hospital.
T
T
Hirata
Department of Breast and Medical Oncology, National Cancer Center Hospital.
C
C
Shimizu
Department of Breast and Medical Oncology, National Cancer Center Hospital.
N
N
Katsumata
Department of Breast and Medical Oncology, National Cancer Center Hospital.
K
K
Tamura
Department of Breast and Medical Oncology, National Cancer Center Hospital; Department of Clinical Trial Coordination and Developmental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
Y
Y
Fujiwara
D000970:Antineoplastic Agents / Q000627:therapeutic use; D054869:Clinical Audit; D026661:Clinical Trials Data Monitoring Committees / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval; D028744:Ethics Committees, Research; D006801:Humans; D007564:Japan; D009369:Neoplasms / Q000188:drug therapy
D000970:Antineoplastic Agents