Chang Jason J, Xu Jianqing, Fan Daimin
National Institute of Clinical Drug Studies at The Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.
Contemp Clin Trials. 2008 Sep;29(5):654-62. doi: 10.1016/j.cct.2008.03.002. Epub 2008 Mar 19.
Due to the extremely competitive market, the pharmaceutical industry has been conducting clinical drug studies in emerging markets such as Russia, India and China, and submits data for new drug approval. But whether or not they follow the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines remains a critical concern to FDA. Site visit reports of the Comprehensive International Program of Research on AIDS (CIPRA), an international research program on HIV/AIDS sponsored by the US National Institutes of Health, were pulled out to compare the studies of the China CIPRA program and the US studies for GCP adherence. To compare adherence, GCP data were abstracted from the reports and transcribed into an assessment tool, which recorded GCP activities. The frequency distribution for the responses to each individual item was examined. The generalized linear model was used to assess the adherence differences between the China CIPRA studies and US studies. In addition, a multinomial generalized linear regression model with GEE analysis was conducted on the assessment of the overall GCP performance using the variables - group (China vs. US) and three level of GCP adherence. The GCP adherence data of the two groups were similar in distribution pattern. The difference of the protocol adherence area was statistically significant between the two groups (p=0.0425). Specifically, the China group had less "failure to perform study procedures or to obtain authorization to deviate" than the US group (13(81.25%) vs. 8(47.06%, p=0.0488)). There was no significant difference (p=1.0000) on the overall GCP performance between the two groups (China vs. US), for three level of GCP adherence. As a preliminary study, our results showed that the China CIPRA program was at least equivalent to the US studies in overall from ICH/GCP perspective.
由于市场竞争极为激烈，制药行业一直在俄罗斯、印度和中国等新兴市场开展临床药物研究，并提交新药审批数据。但它们是否遵循国际协调会议（ICH）和良好临床实践（GCP）指南仍是美国食品药品监督管理局（FDA）极为关注的问题。美国国立卫生研究院资助的一项关于艾滋病毒/艾滋病的国际研究项目——综合国际艾滋病研究项目（CIPRA）的现场考察报告被提取出来，以比较中国CIPRA项目的研究与美国研究在GCP依从性方面的情况。为了比较依从性，从报告中提取GCP数据并转录到一个评估工具中，该工具记录GCP活动。检查了对每个单独项目的回答的频率分布。使用广义线性模型评估中国CIPRA研究与美国研究之间的依从性差异。此外，使用变量——组（中国与美国）和GCP依从性的三个水平，对总体GCP表现进行评估，进行了带有广义估计方程（GEE）分析的多项广义线性回归模型。两组的GCP依从性数据在分布模式上相似。两组在方案依从性方面的差异具有统计学意义（p = 0.0425）。具体而言，中国组“未执行研究程序或未获得偏离授权”的情况比美国组少（13例（81.25%）对8例（47.06%，p = 0.0488））。对于GCP依从性的三个水平，两组（中国与美国）在总体GCP表现上没有显著差异（p = 1.0000）。作为一项初步研究，我们的结果表明，从ICH/GCP角度来看，中国CIPRA项目在总体上至少与美国研究相当。
