Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers.
Purpose: Recently global clinical trials are conducted vigorously and rigorously in line with the guideline of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use of Good Clinical Practice. Since to confirm the current situation of clinical trials in Asia is critical for improving the practice of global clinical trials, we conducted the research in Beijing and in Shanghai consequently. But China is such a huge country that it is difficult for us to evaluate the whole country’s situation by evaluating data of two largest cities. Therefore the purpose of this study is to conduct the research on the detail of current situation of clinical trials in Nanchang, 25th largest city in China. Methods: Questionnaires were administered to medical doctors belonging to institutes affiliated to Nanchang University in Nanchang, 25th largest city in China. Results: The questionnaires were administered to 192 medical doctors and 172 of them were analyzed. There were significant differences between institutes in relation to getting reports from the external authorities after audits and inspections by external authorities. In total, 70.0%, 88.0%, and 100.0% of respondents from Institute A, Institute B, and Institute C, had a report from external authorities after audits and inspections conducted by external authorities in a year, respectively. Conclusion: Our research suggests clinical trials not only in Shanghai and Beijing but also in Nanchang, are conducted vigorously and are appropriately monitored by audits and inspections conducted internally by the local institutes and/or by an external authority. Correspondence to: Yoshitoku Yoshida, Faculty of Nursing, Shubun University, 6 Nikko-cho, Ichinomiya, Aichi 491-0938, Japan & Department of Health Care Administration, Graduate School of Medicine, Nagoya University, 65 Tsurumaicho, Showa-ku, Nagoya, Aichi 466-8550, Japan, Tel: +81-586-45-2101; Fax: +815286-45-4410; E-mail: firstname.lastname@example.org