Bivariate associations of company characteristics with clinical trial transparency measures
Transparency measure | Company size | Company location | Product type | ||||||
Large | Non-large | P value | US | Non-US | P value | Biologic | Drug | P value | |
Public availability of all trials median company score (IQR) | 79 (55–93) | 39 (27–74) | 0.07 | 39 (32–91) | 64 (54–84) | 0.25 | 85 (62–100) | 47 (32–82) | 0.005 |
Public availability of patient trials median company score (IQR) | 100 (93–100) | 100 (67–100) | 0.21 | 100 (80–100) | 100 (82–100) | 0.64 | 100 (83–100) | 100 (86–100) | 0.63 |
FDAAA compliance median company score (IQR) | 100 (88–100) | 57 (0–100) | 0.01 | 86 (50–100) | 95 (70–100) | 0.55 | 100 (87–100) | 100 (50–100) | 0.24 |
Data sharing score median company score (IQR) | 100 (80–100) | 20 (20–40) | <0.001 | 50 (20–80) | 89 (20–100) | 0.28 | NA | NA | NA |
Overall score median company score (IQR) | 96 (91–100) | 59 (41–70) | <0.001 | 73 (54–90) | 79 (59–100) | 0.24 | NA | NA | NA |
Data sharing score reflects scores after 30-day amendment period. Mann-Whitney U tests used to determine association between outcome measures and company size, company location and product type. Additional details on company size, company location and products are provided in online supplemental table 4.
FDAAA, Food and Drug Administration Amendments Act; NA, not applicable.