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Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice

C H Mallinckrodt1, J Bell2, G Liu3

  • 1Biogen, Cambridge, MA, USA.

Therapeutic Innovation & Regulatory Science
|February 20, 2020
PubMed
Summary

This paper details estimators for clinical trials that align with ICH E9(R1) guidelines on estimands and intercurrent events. It emphasizes how justifiable assumptions impact the robustness of estimates, crucial for reliable interpretation.

Keywords:
estimandsestimationmissing datasensitivity

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