Analysis of the situation of clinical trials for antidiabetes drugs supported by foreign pharmaceutical industries in China

QIAN Cui-hong; LIAN Gui-yu

Abstract：Objective:To analyze the situation of clinical trials for antidiabetes drugs supported by foreignpharmaceutical industries in China (except Hongkong and Taiwan Area),which can provide references for improving the level of clinical trials.Methods:The clinical trials for antidiabetes drugs supported by foreign pharmaceutical industries in China (registered on the Clinical Trials.gov from Jan 1,2007 to Dec 1,2016) were searched.These trials were analyzed from study phase,sample size,study design,drugs,sponsors and so on.Results:The number of the clinical trials for antidiabetes drugs supported by pharmaceutical industries in China was 108 during the time.among the trials,there were 2 supported by domestic and international cooperation,and 106 supported by foreign pharmaceutical industries alone.There were 52 clinical trials conducted only in China,and 56 multinational clinical trials.In total,52 (47％) were in phase Ⅲ,102 (94％) were interventional studies.The most clinical trials are supported by pharmaceutical companies such as Novo Nordisk,Sanofi,Astrazeneca,Boehringer Ingelheim,Eli Lilly,and Novartis.Conclusion:The level of the clinical trials of antidiabetes drugs in China have gradually been recognized internationally.To participate in more international clinical trials of antidiabetes drugs,we need to further strengthen the construction of medical institutions and improve the policy environment.