Table 1 Characteristics of evidence submitted to DERP by manufacturers
Dossier evidence | n/N (%) |
|---|---|
Number dossiers received | 160 |
Number of drug products included in DERP reports | 541 |
Number of manufacturers submitting dossiers | 41 |
Studies/supplemental data submitted | 7360 |
Studies/supplemental data Included from dossiers | 160 |
Contribution of dossier evidence incremental to standard searching methods | |
Proportion of submitted evidence included | 160/7360 (2.2%) |
Studies/supplemental data included from dossier per review (mean) | 160/40 (4) |
Proportion of all studies in DERP reviews from dossiers | 160/2234 (7.2%) |
Unique study or supplemental data | |
Proportion studies included | 123/160 (76.9%) |
Proportion supplemental data included | 37/160 (23.1%) |
Unpublished studies | |
Proportion of included dossier studies/supplemental data unpublished | 65/160 (40.6%), |
Head to head studies | |
Proportion of included dossier studies | 41/160 (25.6%) |
Proportion of submitted studies | 41/7360 (0.6%) |
Proportion of all head to head studies in DERP reports from dossiers | 41/536 (7.6%) |
Subgroup evidence | |
Proportion of studies included from dossiers with subgroup evidence | 26/160 (16.3%) |
Proportion of all studies in DERP reports on subgroups from dossiers | 26/363 (6.7%) |
Quality of studies (n = 123, excludes supplemental data) | |
Good | 9/123 (7.3%) |
Fair | 97/123 (78.9%) |
Poor | 18/123 (14.6%) |