Saito K, Kodama Y, Ono S, Maida C, Fujimura A, Miyamoto E
Department of Pharmacy, Faculty of Pharmaceutical Sciences, Hokuriku University, Ishikawa, Japan.
Int J Clin Pharmacol Ther. 2008 Aug;46(8):415-20. doi: 10.5414/cpp46415.
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 the latter period targeted 114 hospitals and 189 trials. The inspection of former period was undertaken by the Organization for Pharmaceuticals Safety and Research (OPSR). On the other hand, the latter period was undertaken by the Pharmaceuticals and Medical Devices Agency (PMDA). The total number of deficiencies detected in GCP audits was 1,529 in the former 3-year period (FY1997 - 1999) and 819 in the latter period (FY2004). The total number of deficiencies detected and reported was more than 1.5-fold on an annual basis in the latter period. By category of deficiencies, the proportion of protocol deviations increased from 14.7 (225/1,529) to 45.7% (374/819), while the proportion of errors in case report forms (CRFs) decreased from 43.6 (666/ 1,529) to 27.1% (222/819). There were two remarkable changes in audit findings between FY1997 - 1999 and FY2004; the increase in the proportion of protocol deviations and the decrease in the proportion of CRF-related deficiencies. We think that in Japan the improvement of research environments is needed to provide reliable clinical data responsible for the regulatory standard of GCP.
为描述日本临床试验的可靠性，我们比较了1997年4月至2000年3月（1997 - 1999财年）与2004年4月至2005年3月（2004财年）期间进行的药物临床试验质量管理规范（GCP）审核结果。比较了两个时期GCP审核报告中描述的各类缺陷的数量和比例。前期的审核结果基于对331家医院和775项试验的官方审核。后期的审核针对114家医院和189项试验。前期的检查由药品安全研究组织（OPSR）进行。另一方面，后期由药品和医疗器械局（PMDA）进行。在前期3年期间（1997 - 1999财年）GCP审核中发现的缺陷总数为1529个，后期（2004财年）为819个。后期每年发现和报告的缺陷总数增加了1.5倍以上。按缺陷类别划分，方案偏离的比例从14.7%（225/1529）增至45.7%（374/819），而病例报告表（CRF）中的错误比例从43.6%（666/1529）降至27.1%（222/819）。在1997 - 1999财年和2004财年之间的审核结果有两个显著变化；方案偏离比例增加以及与CRF相关缺陷比例下降。我们认为在日本需要改善研究环境，以提供符合GCP监管标准的可靠临床数据。
