The potential of the estimands framework for clinical pharmacology trials: Some discussion points-Reference-Cited by-同舟云学术

The potential of the estimands framework for clinical pharmacology trials: Some discussion points

Published:2020-03-03 Issue:7 Volume:86 Page:1240-1247
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Ring Arne¹²^ORCID,Wolfsegger Martin J.³^ORCID

Affiliation:

1. University of the Free State Bloemfontein South Africa

2. medac GmbH Wedel Germany

3. Baxalta Innovations GmbH, a Takeda company Vienna Austria

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14233

Reference15 articles.

1. ICH E9 (R1).Addendum on estimands and sensitivity analysis in clinical trials – to the guideline on statistical principles for clinical trials. Step 5. Available at:https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf

2. Beyond “Intent‐to‐treat” and “Per protocol”: Improving assessment of treatment effects in clinical trials through the specification of an estimand;Petavy F;Br J Clin Pharmacol,2020

3. Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice

4. Estimands: A More Strategic Approach to Study Design and Analysis

5. Defining treatment effects: A regulatory perspective

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