Table 3 Publication and registration of the pivotal studies (n = 108)
From: Clinical evidence for orphan medicinal products-a cause for concern?
| Â | Number of pivotal studies (%) |
|---|---|
Publication in peer-reviewed international journal | |
 Yes | 76 (70.3%) |
Registration on EUdraCT | |
 Yes | 21 (19.4%) |
Registration on ClinicalTrials.gov | |
 Yes | 52 (48.1%) |
Approval by Ethics Committee | |
 Yes | 77 (71.3%) |
 No | 2 (1.9%) |
 Not reported | 29 (26.9%) |