Table 4 Protocol violation reporting and protocol violation frequency.
From: Failure to report protocol violations in clinical trials: a threat to internal validity?
Protocol Violation Type | Percent (number) of trials | Proportion of Enrolled Participants with PVs Median (range) Calculated from trials with Explicit Reporting |
|---|---|---|
Enrolment PVs | ||
Explicit reporting | 12.5% (10/80) | 0.8% (1.6% to 9.1%) |
Incomplete reporting | 8.8% (7/80) | |
Absent | 78.8% (63/80) | |
Randomisation PVs | ||
Explicit reporting | 8.8% (7/80) | 0.7% (0.04% to 7.7%) |
Incomplete reporting | 1.3% (1/80) | |
Absent | 90.0% (72/80) | |
Study Intervention PVs | ||
Explicit reporting | 21.2% (17/80) | 1.3% (0% to 13.2%) |
Incomplete reporting | 21.2% (17/80) | |
Absent | 57.5% (46/80) | |
Patient compliance PVs | ||
Explicit reporting | 47.5% (38/80) | 7% (0.2% to 87%) |
Incomplete reporting | 25.0% (20/80) | |
Absent | 27.5% (22/80) | |
Data Collection PVs | ||
Explicit reporting | 21.3% (17/80) | 1.7% (0.0% to 16.1%) |
Incomplete reporting | 18.8% (15/80) | |
Absent | 60.0% (48/80) |