Table 2.
Availability premarketing randomized active-control trials of new medicines
| Characteristics | Without | RaCT | With | RaCT | Crude odds ratio (95% CI) |
|---|---|---|---|---|---|
| Number of trials | 64 | 52.5% | 58 | 47.5% | |
| Year of authorization | |||||
| 1999 | 9 | 14.1% | 10 | 17.2% | 1.00 |
| 2000 | 5 | 7.8% | 10 | 17.2% | 0.56 (0.14, 2.26) |
| 2001 | 13 | 20.3% | 11 | 19.0% | 1.31 (0.39, 4.39) |
| 2002 | 11 | 17.2% | 10 | 17.2% | 1.22 (0.35, 4.26) |
| 2003 | 7 | 10.9% | 3 | 5.2% | 2.59 (0.51, 13.17) |
| 2004 | 11 | 17.2% | 9 | 15.5% | 1.36 (0.39, 4.79) |
| 2005 | 8 | 12.5% | 5 | 4.1% | 1.78 (0.42, 7.47) |
| Therapeutic indication | |||||
| Cancer | 10 | 15.6% | 6 | 10.3% | 1.61 (0.54, 4.73) |
| Diabetes mellitus | 0 | 7 | 12.1% | NA | |
| HIV-1 infections | 1 | 1.6% | 9 | 15.5% | 0.09 (0.01, 0.71) |
| Rheumatoid arthritis | 3 | 4.7% | 2 | 3.4% | 1.38 (0.22, 8.55) |
| Orphan drug | 14 | 21.9% | 0 | NA | |
| Biotechnological product | 26 | 40.6% | 16 | 27.6% | 1.80 (0.84, 3.85) |
| New mechanism of action | 41 | 64.1% | 15 | 25.9% | 5.11 (2.35, 11.13) |