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. 2021 Apr;10(4):279-282.
doi: 10.1002/psp4.12617.

Estimands-What they are and why they are important for pharmacometricians

Mouna Akacha  1 , Christian Bartels  1 , Björn Bornkamp  1 , Frank Bretz  1 , Neva Coello  1 , Thomas Dumortier  1 , Michael Looby  1 , Oliver Sander  1 , Heinz Schmidli  1 , Jean-Louis Steimer  1 , Camille Vong  1
Affiliations

Estimands-What they are and why they are important for pharmacometricians

Mouna Akacha et al. CPT Pharmacometrics Syst Pharmacol. 2021 Apr.
No abstract available

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Conflict of interest statement

The authors declared no competing interests for this work.

Figures

FIGURE 1
FIGURE 1
Journeys of four patients illustrating intercurrent events that occur after randomization and affect either the interpretation or the existence of the measurements associated with the primary variable. Patient 1 reduces the dose (e.g., due to an adverse event) and remains in the efficacy follow‐up. Patient 2 also reduces the dose (e.g., due to an adverse event) but withdraws at a later timepoint from further follow‐up. Patient 3 dies while on treatment
See this image and copyright information in PMC

References

    1. Sheiner LB. The intellectual health of clinical drug evaluation. Clin Pharmacol Therapeut. 1991;50(1):4‐9. - PubMed
    1. Sheiner LB, Rubin DB. Intention‐to‐treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995;57(1):6‐15. - PubMed
    1. Bernstein GS. Clinical effectiveness of an aerosol contraceptive foam. Contraception. 1971;3:37‐43.
    1. ICH . Topic E9(R1) on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. 2019. www.ich.org
    1. Imbens GW, Rubin DB. Causal Inference in Statistics, Social, and Biomedical Sciences. Cambridge: Cambridge University Press; 2015.

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