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Table 5 Summary of study design of all orphan medicinal products (n = 59)

From: Clinical evidence for orphan medicinal products-a cause for concern?

 

Number of OMPs (%) (n = 59)

Control arm

  At least one study with placebo or standard of care as control

44 (74.6%)

Randomization

  At least one study with random design

46 (78.0%)

Blinding

  At least one study with double blind design

34 (57.6%)