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Compliance with Good Clinical Practice in oncology registration trials in Japan

K Yonemori1, A Hirakawa2, M Ando3

  • 1Department of Breast and Medical Oncology, National Cancer Center Hospital.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|December 2, 2010
PubMed
Abstract

Insights

Oncology drug trials in Japan showed moderate Good Clinical Practice (GCP) compliance, with fewer patient exclusions than other drug types. Overall quality in oncology registration trials was slightly better, though not statistically significant.

Area of Science:

  • Clinical trial quality assurance
  • Pharmaceutical regulatory affairs
  • Oncology drug development

Background:

  • Assessing Good Clinical Practice (GCP) quality in Japanese oncology drug registration trials.
  • Focus on New Drug Application (NDA) and supplemental NDA (sNDA) submissions.

Purpose of the Study:

  • To evaluate GCP compliance in oncology registration trials.
  • To compare oncology trial quality against other therapeutic areas.

Main Methods:

  • Analysis of 383 audit reports from on-site GCP inspections.
  • Data collected for NDAs/sNDAs reviewed by the Pharmaceuticals and Medical Devices Agency (2004-2009).

Main Results:

  • Deficiencies noted in 37.5% (institution), 32.5% (investigator), 52.5% (sponsor), and 25.0% (IRB) of 40 oncology audits.
  • Patient exclusion due to serious GCP violations occurred in 5.0% of oncology trials versus 11.7% for other drug types.

Conclusions:

  • Oncology registration trials demonstrated moderately better GCP compliance than trials for other diseases.
  • No statistically significant difference in GCP compliance was found between oncology and non-oncology trials.

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