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The potential of the estimands framework for clinical pharmacology trials: Some discussion points
Author(s) -
Ring Arne,
Wolfsegger Martin J.
Publication year - 2020
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14233
Subject(s) - clinical trial , bioequivalence , medicine , clinical pharmacology , guideline , pharmacology , medical physics , intensive care medicine , pharmacokinetics , pathology
The recently finalised and published guideline ICH E9 (R1) introduced a new framework for the statistical analysis of clinical trials, namely that of “estimands”. While the framework was originally developed for the analysis of late‐phase trials, it could also provide a rigorous basis for the analysis of clinical pharmacology trials. We illustrate potential applications on two examples: a multiple dose pharmacology trial and the interpretation of confirmatory bioequivalence (BE) trials according to the current FDA and EMA BE guidelines.