Table 2

Sample characteristics

N (%)
Companies42
 Size
  Large17 (40)
  Non-large25 (60)
 Headquarter location
  US26 (62)
  Non-US16 (38)
Products62
 Type
  Drugs40 (65)
  Biologics22 (35)
 FDA approval year
  201616 (26)
  201746 (74)
Trials1017
 Trials conducted in patients391 (38)
 FDAAA applicable trials236 (23)
 Median number of trials supporting each product approval (IQR)13 (8–21)
 Median number of trials in patients for approved indication supporting each product approval (IQR)5 (3–8)
 Median number of FDAAA applicable trials supporting each product approval (IQR)3 (2–5)
  • FDA, Food and Drug Administration; FDAAA, FDA Amendments Act.