Table 2.
Data on clinical development of new medicines
| Phase I | Phase II | Phase III | |
|---|---|---|---|
| Success rates (%)11 | 54 | 34 | 70 |
| Average cycle time (years)11 | 1.5 | 2.5 | 2.5 |
| Probability of success to market from key milestones, 2006-08 (%)12 | 5 | 11 | 66 |
| Causes of failure: 2011-12 (%)13: | |||
| Efficacy | 59 | 52 | |
| Safety | 22 | 35 | |
| Other | 19 | 13 | |
| Median No of participants, 2000-1014: | |||
| Standard medicine | 1708 | ||
| Orphan medicine | 438 | ||
Median review time for a drug application during 2001-10 was 322 days for the Food and Drug Administration and 366 for the European Medicines Agency15; 91% of submissions are successful.11