Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Ratitch, B; Goel, N; Mallinckrodt, C; Bell, J; Bartlett, JW; Molenberghs, G; Singh, P; Lipkovich, I; O'Kelly, M

O'Kelly, M (corresponding author), IQVIA, Estuary House,East Point Business Pk, Dublin 3, Ireland.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020; 54 (2): 370

Abstract

This paper provides examples of defining estimands in real-world scenarios following ICH E9(R1) guidelines. Detailed discussions on choosing the estim......

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