To analyze the strengths and weaknesses of China’s R&D in obesity/overweight drug clinical trials by comparing domestic and international trial characteristics, and put forward suggestions based on national conditions.
Clinical trial data of drugs for overweight/obesity were retrieved from ClinicalTrials.gov (CT.gov) and the China Drug Clinical Trial Registration and Information Disclosure Platform (Registration Platform), and divided into a domestic trial group and an international trial group. A bibliometric method was used for comparative analysis from the dimensions of drug type, dosage form, trial design, number of trials, age, gender, and sample size.
Domestically, chemical drugs dominated (77.57%, 211 cases/271 cases), while international trail chemical drugs (51.30%, 256 cases/499 cases) and biological products (48.30%, 241 cases/499 cases) developed balancedly. Domestic trials focused on tablets (46.32%, 126 cases/271 cases) and injections (47.06%, 128 cases/271 cases), whereas international trials were dominated by injections (57.52%, 287 cases/499 cases) (P<0.001). Domestic randomization rate (92.25%, 250 cases/271 cases) was much higher than overseas (79.56%, 397 cases/499 cases), but blinding application was lower (44.65%, 121 cases/271 cases vs. 65.33%, 326 cases/499 cases). Few domestic trials included children (1.11%, 3 cases/271 cases), with only 3 female-specific studies.
Global obesity/overweight drug trials are mainly in China and the US, but China lags behind with unbalanced structure and insufficient population representativeness. China should improve R&D level through policy incentives and international cooperation based on clinical needs.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |