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Table 3 Publication and registration of the pivotal studies (n = 108)

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

  Number of pivotal studies (%)
Publication in peer-reviewed international journal
 Yes 76 (70.3%)
Registration on EUdraCT
 Yes 21 (19.4%)
Registration on ClinicalTrials.gov
 Yes 52 (48.1%)
Approval by Ethics Committee
 Yes 77 (71.3%)
 No 2 (1.9%)
 Not reported 29 (26.9%)