Use the ICH E9(R1) estimand attributes to turn a vague trial objective into a precise treatment-effect question.
The draft objective says: Assess whether Drug A improves fatigue in rheumatoid arthritis. ICH E9(R1) estimand attributes: population, treatment, variable, intercurrent events, and summary measure The vague objective hides decisions about comparator, timing, rescue medication, and what numerical contrast will be interpreted. Population Adults with moderate rheumatoid arthritis receiving stable background methotrexate. The population defines whose treatment effect the trial is trying to estimate. It is not the same as a recruitment slogan. Treatment condition Drug A 100 mg daily compared with matching placebo, both on background methotrexate. The comparator matters because improvement has meaning only relative to an alternative.…
Sign up free — one personalized lesson every day, matched to your role and goals.
Already have an account? Sign in