Table 1 Classification of outcomes of drug RCTs based on results reported for primary endpoints
From: Recommendations for a uniform assessment of publication bias related to funding source
Positive outcome | Negative outcome | |
|---|---|---|
Results for primary endpoint statistically significant and supporting the efficacy of test drug | X | |
Results for primary endpoint do not reach statistical significance | X | |
Results for primary endpoint statistically significant in direction of control treatment being more efficacious | X | |
Treatments equivalent regarding primary endpoint in non-inferiority or equivalence trials | X | |
Treatments equally effective regarding primary endpoint in trials not explicitly described as superiority or non-inferiority study | X | |
Test drug as safe or safer than control treatment in trials with safety parameter as primary endpoint | X | |
Treatments equally harmful in trials with safety parameter as primary endpoint, when hypothesized that test drug is expected to be safer than control | X | |
Results for >50% of (primary) endpoints statistically significant in favour of test drug, when no/multiple primary endpoints are reported | X | |
Results for one primary endpoint statistically significant in favour of test drug, when two co-primary endpoints are reported | X | |
Treatment effects not compared between groups but against baseline in each arm; results for primary endpoint statistically significant in favour of test drug | X |