Table 2.
Estimand attribute | Guidance |
---|---|
A. Treatment | Same for each disease / subtype |
B. Population | Different for each disease / subtype (but could have a common denominator, e.g., a positive biomarker) |
C. Variable |
Could vary as the same drug could target different aspects in different populations (e.g., in oncology: OS, PFS, ORR) |
D. Intercurrent events | Population‐specific IEs would be different, whereas treatment‐specific IEs would be the same |
E. Population‐level summary | Would change with the variable and the population (e.g., a same binary variable could lead to percent difference in one population and odds ratio in the other if adjustment is needed) |
IEs, intercurrent events; OS, overall survival; ORR, observed response rate; PFS, progression‐free survival.