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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