Counterfactual study* times, real scenario study times, and days (years) saved
Study | Study type | Total counterfactual study time (days) | Observed days specified by design | Days saved | Years saved |
A | PAS | 5569 | 1825 | 3744 | 10.3 |
B | PAS | 3312 | 1825 | 1487 | 4.1 |
C | PAS | 6421 | 1825 | 4596 | 12.6 |
D | PAS | 4432 | 1825 | 2607 | 7.1 |
E | PAS for a labeling expansion | 2346 | 1825 | 521 | 1.4 |
F | PAS for a labeling expansion | 4931 | 3650 | 1281 | 3.5 |
G | PAS | 4342 | 1825 | 2517 | 6.9 |
H | PAS for a labeling expansion | 4931 | 3650 | 1281 | 3.5 |
I | PAS for a labeling expansion | 3447 | 1825 | 1622 | 4.4 |
J | PAS for a labelling expansion | 2220 | 1825 | 395 | 1.1 |
K | PAS for larger size value | 2003 | 1825 | 178 | 0.5 |
L | PAS for a labeling expansion | 4773 | 3650 | 1123 | 3.1 |
M | PMA study for labeling expansion | 2203 | 1825 | 378 | 1.0 |
N | PMA study for labeling expansion | 2203 | 1825 | 378 | 1.0 |
O | PAS for labeling expansion | 2203 | 1825 | 378 | 1.0 |
P | PAS for labeling expansion | 2077 | 1825 | 252 | 0.7 |
Q† | PAS for minor iteration | 2585 | 1825 | 760 | 2.1 |
R† | PAS for precaution removal | 2585 | 1825 | 760 | 2.1 |
S† | PAS for minor iteration | 3084 | 1825 | 1259 | 3.4 |
T† | PAS | 3605 | 1825 | 1780 | 4.9 |
U† | PMA study for labeling expansion bundled | 635 | 365 | 270 | 0.7 |
V† | PAS for labeling expansion | 635 | 365 | 270 | 0.7 |
*Note. The counterfactual studies listed here include all possible counterfactual studies needed to support the regulatory decisions discussed in this paper. Table 1 represents a subset of these studies, which were used in the calculation of ROI.
†Studies not included in the ROI calculation.
PAS, postapproval study; ROI, return on investment.