The potential of the estimands framework for clinical pharmacology trials: Some discussion points.
- Resource Type
- Article
- Authors
- Ring, Arne; Wolfsegger, Martin J.
- Source
- British Journal of Clinical Pharmacology. Jul2020, Vol. 86 Issue 7, p1240-1247. 8p. 2 Diagrams, 2 Charts.
- Subject
- *CLINICAL pharmacology
*CLINICAL trials
*DRUG development
*QUANTITATIVE research
*CLINICAL drug trials
*PHARMACOLOGY
- Language
- ISSN
- 0306-5251
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. [ABSTRACT FROM AUTHOR]