Key characteristics of the clinical study reports in the review
| Section of CSR (corresponding section of E3) | Presence | Length | |
|---|---|---|---|
| CSRs including section, n | CSRs with section length available, n | Median length (range), pages | |
| Synopsis (E3 section 2) | 78 (100%) | 78 | 5 (1–15) |
| Efficacy evaluation (E3 section 11) | 76 (97%) | 77 | 13.5 (2–132) |
| Safety evaluation (E3 section 12) | 77 (99%) | 58 | 17 (2–188) |
| Attached tables not in report text (E3 section 14) | 63 (81%) | 76 | 337 (1–3665) |
| Protocol (E3 section 16.1.1) | 73 (94%) | 41 | 62 (21–139) |
| Blank CRFs (E3 section 16.1.2) | 68 (87%) | 33 | 133 (14–981) |
| Statistical analysis plan (E3 section 16.1.9) | 55 (71%) | 37 | 15 (3–85) |
| Individual participant efficacy listings (E3 section 16.2.6) | 53 (69%) | 19 | 447 (15–21698) |
| Individual participant safety listings (E3 section 16.2.7) | 62 (81%) | 26 | 109.5 (2–10954) |
| Completed CRFs (E3 section 16.3.2) | 16 (21%) | 1 | 765 |
CRFs, case report forms; CSRs, clinical study reports; E3, ICH E3.