Table 4 Analysis of REC comments - non-industry (n = 122) vs industry-sponsored trials (n = 104)
Review criteria | Protocols with comments, n (%) | Relative risk (95% CI)* | P-value |
|---|---|---|---|
1. Proportionality | 61 (27.0) | ||
Non-industry | 34 (27.9) | 0.95 (0.62-1.45) | .805 |
Industry | 27 (26.0) | ||
2. Minimisation of risks & burdens | 26 (11.5) | ||
Non-industry | 15 (12.3) | 0.92 (0.44-1.91) | .820 |
Industry | 11 (10.6) | ||
3. Privacy & confidentiality | 63 (27.9) | ||
Non-industry | 29 (23.8) | 0.93 (0.65-1.34) | .695 |
Industry | 34 (32.7) | ||
4. Patient safety | 61 (27.0) | ||
Non-industry | 36 (29.5) | 1.31 (0.84-2.04) | .228 |
Industry | 25 (24.0) | ||
5. Recruitment process | 47 (20.8) | ||
Non-industry | 30 (24.6) | 1.05 (0.63-1.73) | .866 |
Industry | 17 (16.3) | ||
6. Information sheet & consent form | 182 (80.5) | ||
Non-industry | 100 (82.0) | 1.04 (0.94-1.13) | .468 |
Industry | 82 (78.8) | ||
7. Subject selection | 62 (27.4) | ||
Non-industry | 44 (36.1) | 1.58 (1.01-2.47) | .045 |
Industry | 18 (17.3) | ||
8. Protection vulnerable subjects | 9 (4.0) | ||
Non-industry | 6 (4.9) | 1.53 (0.38-6.07) | .549 |
Industry | 3 (2.9) | ||
9. Methodology & statistical analysis | 160 (70.8) | ||
Non-industry | 95 (77.9) | 1.18 (1.01-1.37) | .038 |
Industry | 65 (62.5) | ||
10. Product information | 65 (28.8) | ||
Non-industry | 38 (31.1) | 1.16 (0.75-1.78) | .507 |
Industry | 27 (26.0) | ||
11. Supporting documentation | 154 (68.1) | ||
Non-industry | 72 (59.0) | 0.83 (0.72-0.95) | .006 |
Industry | 82 (78.8) | ||
12. Facilities & research staff | 57 (25.2) | ||
Non-industry | 39 (32.0) | 1.60 (0.98-2.60) | .060 |
Industry | 18 (17.3) | ||
13. Financial aspects | 39 (17.3) | ||
Non-industry | 25 (20.5) | 1.65 (0.90-3.01) | .103 |
Industry | 14 (13.5) |