Table 2

Key characteristics of the clinical study reports in the review

Section of CSR (corresponding section of E3)PresenceLength
CSRs including section, nCSRs with section length available, nMedian length (range), pages
Synopsis (E3 section 2)78 (100%)785 (1–15)
Efficacy evaluation (E3 section 11)76 (97%)7713.5 (2–132)
Safety evaluation (E3 section 12)77 (99%)5817 (2–188)
Attached tables not in report text (E3 section 14)63 (81%)76337 (1–3665)
Protocol (E3 section 16.1.1)73 (94%)4162 (21–139)
Blank CRFs (E3 section 16.1.2)68 (87%)33133 (14–981)
Statistical analysis plan (E3 section 16.1.9)55 (71%)3715 (3–85)
Individual participant efficacy listings (E3 section 16.2.6)53 (69%)19447 (15–21698)
Individual participant safety listings (E3 section 16.2.7)62 (81%)26109.5 (2–10954)
Completed CRFs (E3 section 16.3.2)16 (21%)1765
  • CRFs, case report forms; CSRs, clinical study reports; E3, ICH E3.