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Table 1 Characteristics of novel drugs approved by the FDA based on pivotal trials using surrogate markers of disease between 2005 and 2012 with at least one matched controlled postapproval study

From: Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study

Characteristic N (%)
Total indications 27 (100.0)
Agent type
 Pharmacologic 24 (88.9)
 Biologic 3 (11.1)
Orphan status
  No 24 (88.9)
  Yes 3 (11.1)
Approval pathway
  Regular 24 (88.9)
  Accelerated 3 (11.1)
Priority review
  Standard 19 (70.4)
  Priority 8 (29.6)
Therapeutic area
  Cardiovascular disease, diabetes mellitus 11 (40.7)
  Infectious disease 6 (22.2)
  Cancer 2 (7.4)
  Other 8 (29.7)