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Table 4 Analysis of REC comments - non-industry (n = 122) vs industry-sponsored trials (n = 104)

From: Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

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)   
  1. * Relative risks are controlled for the REC that reviewed the protocol.
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