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Estimands: A More Strategic Approach to Study Design and Analysis
Author(s) -
Akacha Mouna,
Kothny Wolfgang
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.872
Subject(s) - harmonization , clarity , addendum , clinical trial , biostatistics , research design , clinical study design , management science , computer science , actuarial science , medicine , risk analysis (engineering) , econometrics , political science , statistics , public health , business , engineering , economics , mathematics , law , biochemistry , chemistry , physics , nursing , acoustics
Do we always precisely define the treatment effects that our clinical trial will estimate? Our tenet is that this is not always done, or is done inadequately. This lack of clarity can result in a misalignment among trial objectives, trial design, and statistical methods. We will discuss these challenges and present an improved framework using estimands that is proposed in a draft International Council for Harmonization (ICH) E9 addendum.