Table 2.

Final PAS cost estimation model.

		Per Subject Cost	Per Site Cost	Study Overhead	Notes:
Base Case:	Assumes a 2yr observational follow up of existing study cohort, with one phone evaluation per year	$600	$2,800	$400,000
Adjustments:	Need to Recruit Subjects	$2,600	$3,250	$325,000	De novo cohort required
	Adding a control group (1:1)	$325	$406	$40,625	Due to complexity of recruiting patients to two therapies
	Requiring Randomization	$1,300	$1,625	$162,500
	Additional Phone evaluations per year	$28	$129	$-	Per additional phone interview per year
	In-Person clinical evaluations	$138	$644	$-	Per additional in-person clinical evaluation per year
	Imaging study required	$1,000	$250	$50,000	Examples: Chest CT, renal ultrasound, echocardiogram
	Required invasive study	$2,000	$500	$100,000	Examples: coronary angiography, EGD, ERCP
	Extending additional year (w/ one eval per year)	$198	$924	$264,000	Per year costs
	Large Study Adjustments:
	Overhead Costs for >1000 subjects	$-	$-	$200,000	Per 1000 additional subjects
	Overhead Costs for >100 sites	$-	$-	$300,000	Per 100 additional sites
	Reduced base-case cost if OUS sites	$480	$2,240	$320,000	Based on proportion of study performed OUS
	Discount for non CV Organ system device study	$(120)	$(560)	$(80,000)