Table 9 Quality of reporting of the pivotal studies (n = 108)
From: Clinical evidence for orphan medicinal products-a cause for concern?
| Â | Number of pivotal studies (%) |
|---|---|
Reporting of an a priori stated research hypothesis | |
 Yes | 71 (65.7%) |
 No | 12 (11.1%) |
 Not reported | 25 (23.1%) |
Reporting of main endpoints | |
 Yes | 101 (93.5%) |
Reporting of sampling criteria | |
 Yes | 100 (92.6%) |
Description (i.e. age, gender) of patients included | |
 Yes | 70 (64.8%) |
Reported possible bias and/or confounding | |
 Yes | 45 (41.7%) |
Reporting of the intervention | |
 Yes | 107 (99.1%) |
Reporting of point estimates | |
 Yes, for all primary and secondary endpoints | 39 (36.1%) |
 Yes, but partially | 67 (62.0%) |
 No | 2 (1.9%) |
Reporting of measures of variability | |
 Yes, for all primary and secondary endpoints | 15 (13.9%) |
 Yes, but partially | 59 (54.6%) |
 No | 34 (31.5%) |
Reporting of actual probability values | |
 Yes | 73 (67.6%) |