Table 3

Counterfactual study* times, real scenario study times, and days (years) saved

StudyStudy typeTotal counterfactual study time (days)Observed days specified by designDays savedYears saved
EPAS for a labeling expansion234618255211.4
FPAS for a labeling expansion4931365012813.5
HPAS for a labeling expansion4931365012813.5
IPAS for a labeling expansion3447182516224.4
JPAS for a labelling expansion222018253951.1
KPAS for larger size value200318251780.5
LPAS for a labeling expansion4773365011233.1
MPMA study for labeling expansion220318253781.0
NPMA study for labeling expansion220318253781.0
OPAS for labeling expansion220318253781.0
PPAS for labeling expansion207718252520.7
Q†PAS for minor iteration258518257602.1
R†PAS for precaution removal258518257602.1
S†PAS for minor iteration3084182512593.4
U†PMA study for labeling expansion bundled6353652700.7
V†PAS for labeling expansion6353652700.7
  • *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.