Table 3

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.