Estimands: bringing clarity and focus to research questions in clinical trials.
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ABSTRACT:
SUBMITTER: Clark TP
PROVIDER: S-EPMC8724703 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Estimands: bringing clarity and focus to research questions in clinical trials.
Clark Timothy Peter TP Kahan Brennan C BC Phillips Alan A White Ian I Carpenter James R JR
BMJ open 20220103 1
Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all r ...[more]
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