Reliability of Japanese clinical trials estimated from GCP audit findings.

@article{Saito2008ReliabilityOJ,
  title={Reliability of Japanese clinical trials estimated from GCP audit findings.},
  author={Kazuyuri Saito and Yasuo Kodama and Shunsuke Ono and Chie Maida and Akio Fujimura and Etsuko Miyamoto},
  journal={International journal of clinical pharmacology and therapeutics},
  year={2008},
  volume={46 8},
  pages={415-20}
}
To describe the reliability of Japanese clinical trials, we compared the results of a Good Clinical Practice (GCP) audit conducted between April 1997 and March 2000 (fiscal year (FY) 1997 - 1999) with those from April 2004 - March 2005 (FY2004). The number and proportion 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… CONTINUE READING