The quality of conduct in Japanese clinical trials: Deficiencies found in GCP inspections

Controlled Clinical Trials

Volumn 23, Issue 1, 2002, Pages 29-41

  Ono, Shunsuke ^a,d   Kodama, Yasuo ^b   Nagao, Taku ^c   Toyoshima, Satoshi ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^b Organization for Pharmaceutical Safety and Research   (Japan)

^c UNIVERSITY OF TOKYO   (Japan)

^d Japan Ministry of Health Labour and Welfare   (Japan)

Author keywords

Good clinical practice; Japanese clinical trials; Research environment

Indexed keywords

CLINICAL PRACTICE; CLINICAL TRIAL; DRUG USE; ENVIRONMENTAL MONITORING; ERROR; GOOD CLINICAL PRACTICE; HISTORY; HOSPITAL; INFORMATION CENTER; INFORMED CONSENT; JAPAN; MEDICAL AUDIT; MEDICAL PRACTICE; MEDICAL RESEARCH; MEDICAL SOCIETY; NURSE; PHARMACY; PREVALENCE; QUALITY CONTROL; REVIEW; UNITED STATES;

EID: 0036171894     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(01)00182-9     Document Type: Article

References (21)

1. International comparison of conception on placebo use in clinical trials
2. Clinical trials and the new good clinical practice guideline in Japan
3. Recent findings in the GCP inspection
4. Background issues in Japan affecting the ethical review process for clinical trials
5. Impact of the new GCP regulation on clinical trials in Japan
6. Pharmaceutical prices, quantities and innovation. Comparing Japan with the US
7. Considerations on the quality of clinical trials
8. Japan's new GCP regulations and their impact on clinical trials
9. Placebo-controlled trials and active-control trials in the evaluation of new treatment
10. Scientific misconduct in investigational drug trials
11. A successful system of scientific data audits for clinical trials: A report from the Cancer and Leukemia Group B
12. Fraud and scientific misconduct in the United States
13. Current status of clinical trials in Japan
14. The GCP audit and the review process