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Comments on 'standard and reference-based conditional mean imputation': Regulators and trial statisticians be aware!

Authors :
Cro S
Morris TP
Roger JH
Carpenter JR
Source :
Pharmaceutical statistics [Pharm Stat] 2024 Sep-Oct; Vol. 23 (5), pp. 598-603. Date of Electronic Publication: 2024 Apr 17.
Publication Year :
2024

Abstract

Accurate frequentist performance of a method is desirable in confirmatory clinical trials, but is not sufficient on its own to justify the use of a missing data method. Reference-based conditional mean imputation, with variance estimation justified solely by its frequentist performance, has the surprising and undesirable property that the estimated variance becomes smaller the greater the number of missing observations; as explained under jump-to-reference it effectively forces the true treatment effect to be exactly zero for patients with missing data.<br /> (© 2024 John Wiley & Sons Ltd.)

Details

Language :
English
ISSN :
1539-1612
Volume :
23
Issue :
5
Database :
MEDLINE
Journal :
Pharmaceutical statistics
Publication Type :
Academic Journal
Accession number :
38631678
Full Text :
https://doi.org/10.1002/pst.2373