Current situation of clinical trials in Beijing and Shanghai, China

OBJECTIVE: Global clinical trials are important because they facilitate rapid delivery of new and effective drugs to patients Assessment of the current situation of clinical trials conducted in Asia is critical for improving performance of global clinical trials. However, review reports from China or other Asian countries are not yet available. Therefore, the purpose of this research was to investigate the current quality of clinical trials conducted in Shanghai, as well as Beijing. METHODS: Questionnaires were distributed to medical doctors attending institutes in Beijing and Shanghai in which clinical trials have been conducted. These questionnaires were delivered and collected from both areas by the Peking University research team of Beijing and the Fudan University research team of Shanghai respectively. Analysis and evaluation were conducted by research teams from both China and Japan. RESULTS: Subjects were randomly selected by the respective research team. A total of 145 questionnaires in Beijing and 162 in Shanghai were administered: all 307 questionnaires were completed. In total, 57.2% and 74.5% of respondents from Beijing and Shanghai, respectively, reported participation in audits and inspections on an annual basis conducted by their own institute. A total of 49.2% and 56.0% of respondents from Beijing and Shanghai, respectively, reported that they received reports after the audits and inspections by an institute. 23.5% and 37.7% of respondents from Beijing and Shanghai, respectively, reported participation in audits conducted annually by external authorities. A total of 18.9% and 29.5% of respondents from Beijing and Shanghai, respectively, reported that they received reports after the audits and inspections by an external authority. CONCLUSIONS: Our research suggests that clinical trials in Shanghai, as well as in Beijing, are conducted vigorously and appropriately monitored by audits and inspections conducted by concerned institutes and/or by an external authority.