Table 3.
Cost Analysis for Pulmonary Arterial Hypertension Clinical Trial
| Study Element | Baseline Cost (USD) | Iterations per Study per ITT Patient | REVEAL 2.0 Screening | COMPERA Screening | French Screening | Nonenrichment Screening |
|---|---|---|---|---|---|---|
| Informed consent processing | 150 | 0 | 1 | 1 | 1 | 1 |
| History and PE | 500 | 0+ | 1 | 1 | 1 | 1 |
| Vital sign assessment | 50 | 3+ | 1 | 1 | 1 | 1 |
| Right heart catheterization | 3,500–5,000 | 0+ | 1 | 1 | 1 | 1 |
| 6-minute-walk test | 550 | 3+ | 1 | 1 | 1 | 1 |
| NT-proBNP | 140 | 0+ | 1 | 1 | — | — |
| Lung capacity test | 500 | — | 1 | — | — | — |
| Mixed venous O2 saturation | 200 | — | 1 | 1 | — | — |
| Creatinine | 50 | 0+ | 1 | — | — | — |
| IRB fees | 4,000 | 1 | — | — | — | — |
| Study drugs | 12,100 | 1 | — | — | — | — |
| Total | $13,900+ per treated patient | $5,640 per patient | $5,090 per patient | $4,750 per patient | $4,750 per patient | |
| $1,800+ per placebo patient | ||||||
Definition of abbreviations: COMPERA = Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension; IRB = institutional review board; ITT = intention to treat; NT-proBNP = N-terminal-proB-type natriuretic peptide; PE = physical examination; REVEAL = Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management; USD = U.S. dollars.
Costs per ITT patient reflects cost for every 12-week period of enrollment in a trial. Costs per ITT patient can vary considerably because of trial design; estimates reflect a minimum, with (+) indicating an anticipated increase.