A comparative method of evaluating quality of international clinical studies in China: Analysis of site visit reports of the Clinical Research Operations and Monitoring Center.

摘要

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.