Table 1.
Characteristics of Cardiometabolic Drug Clinical Trials in China
| Classification | Frequency(%) |
|---|---|
| Status | |
| Proceeding | 851 (34.5%) |
| Completed | 1529 (62.0%) |
| Suspended | 20 (0.8%) |
| Terminated | 66 (2.7%) |
| Trials Phase | |
| Phase IV | 26 (1.1%) |
| Phase III | 278 (11.3%) |
| Phase II | 169 (6.9%) |
| Phase I | 555 (22.5%) |
| Bioequivalence | 1438 (58.3%) |
| Type of drugs | |
| Chemical Drug | 2079 (84.3%) |
| Biological Product | 209 (8.5%) |
| TCM Compound | 97 (3.9%) |
| Ingredient of Natural Drug | 60 (2.4%) |
| NA | 21 (0.9%) |
| Design | |
| Single-arm | 100 (4.1%) |
| Crossover | 1663 (67.4%) |
| Parallel-group | 698 (28.3%) |
| Factorial design | 5 (0.2%) |
| Randomization | |
| Randomization | 2353 (95.4%) |
| Non-randomization | 113 (4.6%) |
| Blinding | |
| Open-label | 1867 (75.7%) |
| Single-blind | 35 (1.4%) |
| Double-blind | 564 (22.9%) |
| Coverage | |
| Domestic | 2401 (97.4%) |
| International Multi-center | 65 (2.6%) |
Abbreviations: NA. Not applicable