Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/31189
Title: Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice
Authors: Mallinckrodt, C. H.
Bell, J.
Liu, G
Ratitch, B.
O'Kelly, M.
Lipkovich, I
Singh, P.
Xu, L.
MOLENBERGHS, Geert 
Issue Date: 2020
Publisher: SPRINGER HEIDELBERG
Source: Therapeutic Innovation and Regulatory Science, 54 (2) , p. 353 -364
Abstract: The draft ICH E9(R1) addendum stipulates that an estimator should align with its associated estimand and yield an estimate that facilitates reliable interpretations. The addendum further stipulates that assumptions should be justifiable and plausible, and that the extent of assumptions is an important consideration for whether an estimate will be robust because assumptions are often unverifiable. The draft addendum specifies 5 strategies for dealing with intercurrent events. The intent of this paper is to provide conceptual considerations and technical details for various estimators that align with these strategies. We include focus on how the nature and extent of assumptions influences the potential robustness of the various estimators. The content reflects the knowledge, experience, and opinions of the Drug Information Association's Scientific Working Group on Missing Data. This group includes experienced statisticians from across industry and academia, primarily in the US and European Union.
Notes: O'Kelly, M (reprint author), IQVIA, Estuary House,East Point Business Pk, Dublin 3, Ireland.
michael.okelly@iqvia.com
Other: O'Kelly, M (reprint author), IQVIA, Estuary House,East Point Business Pk, Dublin 3, Ireland. michael.okelly@iqvia.com
Keywords: estimands;estimation;missing data;sensitivity
Document URI: http://hdl.handle.net/1942/31189
ISSN: 2168-4790
e-ISSN: 2168-4804
DOI: 10.1007/s43441-019-00063-9
ISI #: WOS:000522455300012
Rights: 2020 Springer Nature Switzerland AG. Part of Springer Nature.
Category: A1
Type: Journal Contribution
Validations: ecoom 2021
Appears in Collections:Research publications

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