Estimands and Complex Innovative Designs

Author:

Collignon Olivier1,Schiel Anja2,Burman Carl‐Fredrik3,Rufibach Kaspar4,Posch Martin5,Bretz Frank56

Affiliation:

1. GlaxoSmithKline Hertfordshire UK

2. Norwegian Medicines Agency Oslo Norway

3. Statistical Innovation, Data Science & Artificial Intelligence AstraZeneca Research & Development Gothenburg Sweden

4. Methods, Collaboration, and Outreach Group, Product Development Data Sciences F.Hoffmann‐La Roche Basel Switzerland

5. Section for Medical Statistics Center for Medical Statistics Informatics, and Intelligent Systems Medical University of Vienna Vienna Austria

6. Novartis Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference55 articles.

1. International Council For Harmonisation of Technical Requirements For Pharmaceuticals For Human Use (ICH).ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (2019).

2. Estimands and Their Role in Clinical Trials

3. Estimands in clinical trials - broadening the perspective

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

5. Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice

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