Table 3.
EACTs for investigational drugs with high degree of social and patients demands
| Items | Number of pivotal clinical trials (%) | Number of conducting expanded access clinical trials (%) | Number of not conducting expanded access clinical trials (%) |
|---|---|---|---|
| High degree of social and patients demands | 152 (100.0) | 17 (11.2) | 135 (88.8) |
| Conducting expanded access program in the United States | 25 (100.0) | 5 (20.0) | 20 (80.0) |
| Sakigake designation | 16 (100.0) | 2 (12.5) | 14 (87.5) |
| Orphan drug designation | 104 (100.0) | 16 (15.4) | 88 (84.6) |
| Drugs for development request by MHLW | 31 (100.0) | 0 (0) | 31 (100.0) |
EACTs, Expanded Access Clinical Trials; MHLW, Ministry of Health, Labour, and Welfare.