Table 2

 The Berdeu scale10 and frequency of endorsement (n  =  231)

Itemn (%)
*13 clinical trials (5.6%) reported neither that informed consent had been requested from the participants nor that a REC had approved the research.
†Only 24 articles were described as double blind.
1. Obtaining informed consent from patients*
Yes210 (90.9)
No21 (9.1)
2. Approval by a REC*
Yes154 (66.7)
No77 (33.3)
3. Risk–benefit ratio valuation
Yes5 (2.2)
No226 (97.8)
4. Respect for the principle of a priori equivalence
Yes231 (100)
No0 (0)
5. Refusal of consent
Yes9 (3.9%)
No222 (96.1)
6. Placebo ethical justification†
Yes1
No23
7. Fairness of participant selection (inclusion/exclusion criteria)
Yes230 (>99)
No1 (<1)
8. Planned interim analysis
Yes67 (29.0)
No164 (71.0)
9. Prospectively defined stopping rules
Yes37 (16.0)
No194 (84.0)
10. Independent monitoring committee
Yes33 (14.3)
No198 (85.7)