Table 2 Elicitation methods and rationale to select a margin. Multiple options could be selected by responders
From: How do we know a treatment is good enough? A survey of non-inferiority trials
Elicitation methods | Frequency (%) (N = 41) | ||
|---|---|---|---|
Method/s applied to surveyed trial | Method/s aware of | Method/s to recommend | |
Opinion seeking | 24 (58.5%) | 33 (80.5%) | 28 (68.3%) |
Review of evidence base | 28 (68.3%) | 40 (97.6%) | 36 (87.8%) |
Margin recommendation by guidelines | 22 (53.7%) | 35 (85.4%) | 35 (85.4%) |
Feasibility of sample size | 18 (43.9%) | 35 (85.4%) | 23 (56.1%) |
Other | 0 (0%) | 0 (0.0%) | 2 (4.9%)a |
Underlying principles to select a margin | |||
A realistic difference given the interventions under evaluation | 27 (65.9%) | ||
A difference which would lead to an achievable sample size | 17 (41.5%) | ||
A difference that would be viewed as important by a relevant stakeholder group | 33 (80.5%) | ||
Preserved effect of new treatment compared with an established minimally clinically important difference or an active comparator | 2 (4.9%) | ||