BACKGROUND: Japanese clinical trials have some unique characteristics in both design and conduct. We have studied recent changes in quality in Japanese clinical trials. OBJECTIVE: To describe quantitatively recent drastic changes in Japanese clinical trial environments by comparing the results of Good Clinical Practice (GCP) audits conducted from April 1997 to March 2000 (fiscal year [FY] 1997-1999) with those from April 2000 to March 2001 (FY2000). METHODS: The numbers and proportions of various types of deficiencies described in GCP audit reports were compared between the 2 periods. The audit findings in the former period were based on official audits that covered 331 hospitals and 775 trials. The audits in the latter period targeted 123 hospitals and 279 trials. In both periods, inspections were undertaken by the Organization for Pharmaceutical Safety and Research (OPSR). RESULTS: The total number of deficiencies detected in GCP audits in the former 3-year period (FY1997-1999) was 1529; the number in the next single year (FY2000) was 1151. The total number of deficiencies detected and reported was more than double on an annual basis between the periods. By category of deficiencies, the proportion of protocol deviations increased from 14.7% (n = 225) to 41.4% (n = 477), while the proportion of errors in Case Report Forms decreased from 43.6% (n = 666) to 34.1% (n = 392). CONCLUSIONS: This study shows that the protocol deviations increased in FY2000. The increase in deficiencies may be associated with the regulatory change of applicable standards, increasing attention of the OPSR to such deficiencies, difficulties in improving investigators' behaviors during a short period of time, and insufficient numbers of support staff including clinical research coordinators in research institutions.
BACKGROUND: Japanese clinical trials have some unique characteristics in both design and conduct. We have studied recent changes in quality in Japanese clinical trials. OBJECTIVE: To describe quantitatively recent drastic changes in Japanese clinical trial environments by comparing the results of Good Clinical Practice (GCP) audits conducted from April 1997 to March 2000 (fiscal year [FY] 1997-1999) with those from April 2000 to March 2001 (FY2000). METHODS: The numbers and proportions of various types of deficiencies described in GCP audit reports were compared between the 2 periods. The audit findings in the former period were based on official audits that covered 331 hospitals and 775 trials. The audits in the latter period targeted 123 hospitals and 279 trials. In both periods, inspections were undertaken by the Organization for Pharmaceutical Safety and Research (OPSR). RESULTS: The total number of deficiencies detected in GCP audits in the former 3-year period (FY1997-1999) was 1529; the number in the next single year (FY2000) was 1151. The total number of deficiencies detected and reported was more than double on an annual basis between the periods. By category of deficiencies, the proportion of protocol deviations increased from 14.7% (n = 225) to 41.4% (n = 477), while the proportion of errors in Case Report Forms decreased from 43.6% (n = 666) to 34.1% (n = 392). CONCLUSIONS: This study shows that the protocol deviations increased in FY2000. The increase in deficiencies may be associated with the regulatory change of applicable standards, increasing attention of the OPSR to such deficiencies, difficulties in improving investigators' behaviors during a short period of time, and insufficient numbers of support staff including clinical research coordinators in research institutions.