PMID: 16645429Apr 29, 2006Paper

Quality of Japanese clinical trials estimated from good clinical practice audit findings

American Journal of Therapeutics
Kazuyuki SaitoAkio Fujimura

Abstract

To describe qualitatively recent changes in the Japanese clinical trial environments, we compared the results of the Good Clinical Practice (GCP) audits conducted from April 1997 to March 2000 (FY1997 to FY1999) with those from April 2002 to March 2003 (FY2002). In addition, the audit results were compared between the United States and Japan. The audit findings in the former period were based on the official audits by the Organization for Pharmaceutical Safety and Research (OPSR) that covered 331 hospitals and 775 trials. The audits by the OPSR in the latter period targeted 136 hospitals and 226 trials. The total number of deficiencies detected in the Good Clinical Practice audits in the former 3-year period (FY1997 to FY1999) was 1529, and the number in the single year (FY2002) was 1627. The total number of deficiencies detected and reported was about 3-fold on an annual basis between the periods. By category of deficiencies, there were 2 remarkable changes in the OPSR's audit findings between FY1997-FY1999 and FY2002. One was an increase in the proportion of protocol deviations from 14.7% (225/1529) in FY1997-FY1999 to 48.2% (785/1627) in FY2002, and the other was a decrease in the proportion of case report form-related defic...Continue Reading

References

Sep 13, 2001·Clinical and Experimental Pharmacology & Physiology·J YoshiokaT Nishimura
Feb 20, 2002·Controlled Clinical Trials·Shunsuke OnoSatoshi Toyoshima
Jan 27, 2004·The Annals of Pharmacotherapy·Kazuyuki SaitoAkio Fujimura

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Citations

Jun 17, 2009·International Journal of Technology Assessment in Health Care·Akinori Hisashige
Dec 2, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·K YonemoriY Fujiwara
Mar 9, 2010·Medicina clínica·Ana AldeaCarmen Tristán
Mar 18, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Morihito TakitaMasahiro Kami

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