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Recent changes in quality in Japanese clinical trials
Kazuyuki Saito1, Yasuo Kodama, Shunsuke Ono
1Department of Pharmacology, Division of Clinical Pharmacology, Jichi Medical School, Tochigi, Japan. ZVF02371@nifty.ne.jp
The Annals of Pharmacotherapy
|January 27, 2004
Summary
Japanese clinical trial quality has changed, with protocol deviations significantly increasing in FY2000. This shift highlights evolving challenges in clinical research conduct and oversight.
Area of Science:
- Clinical Research
- Pharmaceutical Auditing
- Regulatory Compliance
Background:
- Japanese clinical trials possess distinct design and operational characteristics.
- Recent shifts in the quality of Japanese clinical trials were investigated.
Purpose of the Study:
- To quantitatively assess significant changes in the Japanese clinical trial landscape.
- To compare Good Clinical Practice (GCP) audit results from FY1997-1999 with FY2000.
Main Methods:
- Compared deficiencies from GCP audit reports between two distinct periods (FY1997-1999 and FY2000).
- Audits covered 331 hospitals and 775 trials (FY1997-1999) versus 123 hospitals and 279 trials (FY2000).
- Inspections were conducted by the Organization for Pharmaceutical Safety and Research (OPSR).
Main Results:
- Annual deficiencies more than doubled from FY1997-1999 to FY2000.
- Protocol deviations increased from 14.7% to 41.4% of all deficiencies.
- Errors in Case Report Forms decreased from 43.6% to 34.1%.
Conclusions:
- A notable rise in protocol deviations occurred in FY2000.
- Increased deficiencies may stem from regulatory changes, heightened OPSR scrutiny, and challenges in investigator behavior modification.
- Insufficient support staff, including clinical research coordinators, may also contribute to the rise in deficiencies.