External comparators and estimands

The estimand framework as defined by the ICH E9(R1) addendum aims to clearly define “the treatment effect reflecting the clinical question posed by the trial objective”. It intends to achieve this goal of a clear definition by specifying the 5 estimand attributes: treatment conditions, population, e...

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Bibliographic Details
Main Author: Gerd Rippin
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-02-01
Series:Frontiers in Drug Safety and Regulation
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1332040/full