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Different Clinical Questions Need Different Estimands.
Oliver Keene1, Helle Lynggaard2, Christine Fletcher3
1KeeneONStatistics, Maidenhead, UK.
The ICH E9(R1) estimands framework guides clinical trial analysis. While the treatment-policy strategy is valuable, other estimands are crucial for addressing clinically relevant questions and should be reported in main trial results.
Area of Science:
- Clinical Trials Methodology
- Pharmaceutical Statistics
- Regulatory Science
Background:
- The International Council for Harmonisation E9(R1) guideline emphasizes precise estimand specification in clinical trials.
- A recent perspective suggests limiting reported results to the treatment-policy strategy, potentially excluding other clinically relevant estimands.
- The treatment-policy strategy estimates the effect of treatment assignment, including outcomes after intercurrent events like treatment discontinuation.
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