Table 1 Characteristics of the Clinical trials data of orphan drugs
From: Current status and trend of clinical development of orphan drugs in China
Item | Overall (n = 331) | Domestic enterprises (n = 194) | Foreign enterprises (n = 137) | χ2 | P value | ||||
|---|---|---|---|---|---|---|---|---|---|
Study phase | Phase I | 58 | 17% | 32 | 16% | 26 | 19% | 47.701 | 0 |
Phase II | 27 | 8% | 9 | 5% | 18 | 13% | |||
Phase III | 78 | 24% | 37 | 19% | 41 | 30% | |||
Phase IV | 16 | 5% | 1 | 1% | 15 | 11% | |||
BE | 152 | 46% | 115 | 59% | 37 | 27% | |||
Trial scope | Domestic trial | 294 | 89% | 183 | 94% | 111 | 81% | 14.323 | 0 |
International trial | 37 | 11% | 11 | 6% | 26 | 19% | |||
DMC | Yes | 35 | 11% | 12 | 6% | 23 | 17% | 9.546 | 0 |
No | 296 | 89% | 182 | 94% | 114 | 83% | |||
Insurance | Yes | 229 | 69% | 124 | 64% | 105 | 77% | 6.098 | 0.014 |
No | 102 | 31% | 70 | 36% | 32 | 23% | |||