Table 1.
Proposed scales and scores for assessing the three components of pertinence of study relevant to small randomised controlled trial under design
Cancer | Treatment | Endpoint | Component score |
---|---|---|---|
Same disease and stage | Same as proposed standard and experimental treatments | Overall survival | 1 |
Same disease, different stage or type of patient | Same standard treatment, similar experimental treatment (eg different dose) | PFS, DFS, or EFS; adjustment factor available | 0.9 |
Different site, same biology/histology | Similar standard and experimental treatments | PFS, DFS, or EFS; adjustment factor unavailable | 0.8 |
Same site, different biology/histology | Response rate validated as a surrogate endpoint | 0.5 | |
Different site, some similarity | Some similarity in standard or experimental treatment, or both | Response rate not validated as surrogate end point | 0.3 |
Different disease | Unrelated treatments | Unrelated end points | 0 |
DFS=disease-free survival, PFS=progression-free survival, EFS=event-free survival.