Dr.Chuangxing Guo of Suzhou Kintor gave a presentation on the implementation of dual declaration of Proxalutamide in China and the United States at the "2017 China Novel Drugs Clinical Development Summit Forum" sponsored by PharmaDJ.Existing data proves that Proxalutamide has obvious advantages in pharmacological activity compared with other AR antagonists,so it is expected to become the best-in-class among the second-generation new AR antagonists.In the dual declaration of Proxalutamide in China and the United States,Dr.Chuangxing Guo compared the important time points of clinical trials in the two countries and found the following differences:
First of all,the United States offers help in Pre-IND communication,which was originally not found in China;in the United States,it takes 3~4 months to collect and compile the IND declaration data,which takes 1~2 months in China;there is no on-site inspection in the United States,which,however,takes 1~2 months in China;in the United States,a lot of work is needed for selection of the first Site/PI (provided with 1572/ICF form),which is relatively easy in China;there is no FDA signature process in the United States,while China's CFDA demands 1~2 months for the process;it takes about 1 month from first submission of IND to receipt of clinical approval in the United States,but now takes about 7 months in China;patient enrollment is slow in the United States ,however,it is much faster in China,and the related cost is significantly higher in the United States than in China.
Dr.Chuangxing Guo raised his views on how to make clinical research faster and better in China and the United States: In terms of declaration,China needs certain sense of foresight and risk control,and capabilities to adjust the pre-clinical research program according to policy changes;in the United States,there is need to find the first Site/PI and IND before CRO selection,collectively to improve the program.In terms of implementation,China needs to strengthen clinical operation team and strengthen communication with departments such as CDE,EC,and the Genetics Office;in the United States,what’s more important is sufficient budget,a sufficient number of Sites,good balance between teaching hospitals and private clinics,enhanced CRO supervision,and direct communication with Principal Investigators as much as possible.
Domestic policies and regulation,which gradually loosen and approach towards the international standard have made more and more local innovation forces spread internationally."Based in China,facing the world" has gradually become the development strategy for local innovative enterprises,and the competition among innovative pharmaceutical enterprises has also focused more on clinical development strategies.