Characteristics of Clinical Trials Conducted in Japan under the New GCP Guideline: Analysis of PMDA Audit Reports

Abstract

This article shows the quality of clinical trials for new drug application which conducted in Japan. To describe characteristics of Japanese clinical trials by comparing the results of good clinical practice (GCP) audits conducted from April 2005 to March 2006 (i.e., fiscal year [FY] 2005) with those from April 1997 to March 2000 (FY1997-1999). The percentage of various types of deficiencies described in GCP audit reports were compared between the two periods. The audit findings were based on official audits that covered 331 hospitals and 775 trials in FY1997-1999 and 120 hospitals and 180 trials in FY2005. The inspection was undertaken by a quasi-governmental organization. The total number of deficiencies detected in GCP audits in FY1997-1999 was 1529; the number in FY2005 was 542. By category of deficiencies, the proportion of protocol deviations increased from 14.7% (225/1529) in FY1997-1999 to 31.4% (72/229) in FY2005, while the proportion of errors in case report forms (CRFs) decreased from 43.6% (666/1529) in FY1997-1999 to 25.3% (58/229) in FY2005. There were two remarkable changes in audit findings between the periods. Because the proportion of protocol deviations is higher in FY2005 than in FY1997-1999, it seems that Japanese clinical trials have problems associated with the conduct of investigators in each institution. We need to pay attention to real changes in the incentives and conduct of the participants in Japanese clinical trial setting.