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Table 2 Estimated clinical costs, expected costs and out-of-pocket clinical costs per approved drug

From: Estimating the clinical cost of drug development for orphan versus non-orphan drugs

Drug Type

Phase

Estimated out-of-pocket clinical costs (in millions of 2013 USD)

Probability of entering phase

Expected out-of-pocket clinical costs (in millions of 2013 USD)

Overall Probability of clinical success

Out-of-pocket clinical cost per approved drug (in millions of 2013 USD)

Non-orphan

1

$2.6

100%

$2.6

10.44%

$291.4

2

$9.9

64.5%

$6.4

3

$102.7

20.9%

$21.5

Total

$30.5

Orphan

1

$3.8

100%

$3.8

32.93%

$166.1

2

$23.7

86.8%

$20.6

3

$49.9

60.8%

$30.3

Total

$54.7

  1. Estimated out-of-pocket clinical costs = costs accrued by the researcher to conduct the trial, Expected out-of-pocket clinical costs = cost accrued by the researcher adjusted for trial success, Overall probability of success = probability of success from phase 1 to regulatory approval