Analysis of the development of clinical resources in Shanghai

By Jiang Yangjun Make up ginger Shanghai is rich in clinical resources in general, leading in carrying capacity of clinical trials in China The main clinical trials undertaken are tumor, urogenital system, endocrine and metabolic system diseases The construction of innovative highland of cell therapy in China has taken shape According to the data of drug clinical trial registration and information publicity platform, from 2013 to September 2019, there were 53 GCP institutions in Shanghai, and 2713 clinical trials (excluding bioequivalence trials) were registered As of October 2019, according to the State Drug Administration, six new drug clinical trial institutions have been established in Shanghai, including Shanghai Yangpu District Shidong hospital, Shanghai Baoshan Luodian hospital, Shanghai International Medical Center, Shanghai Songjiang District Central Hospital, Shanghai Aier Eye Hospital and Shanghai Fourth People's hospital At present, there are 59 drug clinical trial institutions in Shanghai In terms of clinical trial carriers, as of September 2019, 2713 clinical trials conducted in Shanghai involved 53 clinical trial institutions, including Zhongshan Hospital Affiliated to Fudan University (458), Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College (457), Cancer Hospital Affiliated to Fudan University (457) and Shanghai Public Health Clinical Center (310) The main force, but the number of clinical trials carried by it is far behind the domestic leading institutions, such as West China Hospital of Sichuan University (1053 items), the first hospital of Jilin University (983 items), Beijing Union Medical College Hospital (770 items) The main clinical trials undertaken in Shanghai are tumor, endocrine and metabolic system, urogenital system and digestive system At present, among the clinical trials carried out by Shanghai clinical trial institutions, the most indications are tumors (877 items), followed by urogenital system diseases (285 items), endocrine and metabolic system diseases (272 items), which account for 52.9% of the total clinical trials The relevant clinical trial institutions include tumor, infectious diseases, endocrine and metabolic system diseases, etc Surface has formed certain accumulation and advantages Figure 2 distribution of main diseases in clinical trials conducted by clinical trial institutions in Shanghai In terms of serving local enterprises, in the 2713 clinical trials carried out by Shanghai drug clinical trial institutions from 2013 to September 2019, 781 of which served local enterprises, accounting for 28.8% (394 of which were clinical trials conducted by local GCP institutions as team leaders), and there is still a large room for improvement In addition, in addition to the local enterprises in Shanghai, most of the enterprises in Jiangsu and Beijing carry out clinical trials In Pudong New Area, the construction of cell therapy innovation highland in China has taken shape Shanghai is currently at the forefront of the country in R & D resources and innovation capacity of cell therapy In the field of car-t cell therapy, more than 50 cell therapy industry chain enterprises, such as Novartis, yaomingjunuo, Hengrun Dasheng, and ucadi, have gathered As of February 2019, Pudong accounted for 9 of the 15 car-t clinical trial approvals in China On October 25, 2018, Shanghai Hengrun Dashen, a Pudong New Area enterprise, officially launched the first clinical trial of car-t cell therapy in China Shanghai Mingju biology and Keji biology car-t cell clinical trials were respectively undertaken by Pudong New Area Medical Institutions Shanghai Oriental Hospital and Renji Hospital Affiliated to Shanghai Jiaotong University Medical College In addition, Shanghai Oriental hospital established the stem cell engineering transformation hospital center as early as 2012 At present, it has more than 200 outstanding talents in the field of stem cells led by academician Pei gang Depending on the advantages of industry and clinical resources, Pudong can build a domestic and international industrial highland in the field of cell therapy.