What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials?

Abstract Background Published in 2019, a new addendum to the ICH E9 guideline presents the estimand framework as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical analyses, and interpretation of results. The use of the estimand framework...

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Bibliographic Details
Main Authors: Rachael Lawrance, Evgeny Degtyarev, Philip Griffiths, Peter Trask, Helen Lau, Denise D’Alessio, Ingolf Griebsch, Gudrun Wallenstein, Kim Cocks, Kaspar Rufibach
Format: Article
Language:English
Published: SpringerOpen 2020-08-01
Series:Journal of Patient-Reported Outcomes
Subjects:
PRO
ICH
Online Access:http://link.springer.com/article/10.1186/s41687-020-00218-5