Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials

Author:

Collignon Olivier1,Gartner Christian2,Haidich Anna‐Bettina3,James Hemmings Robert4,Hofner Benjamin5,Pétavy Frank6,Posch Martin7,Rantell Khadija8,Roes Kit9,Schiel Anja10

Affiliation:

1. Competence Centre in Methodology and Statistics Luxembourg Institute of Health Strassen Luxembourg

2. AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit/Austrian Agency for Health and Food Safety Vienna Austria

3. Department of Hygiene Social‐Preventive Medicine & Medical Statistics Medical School Aristotle University of Thessaloniki Thessaloniki Greece

4. Consilium Hemmings Unit 96, The Maltings Business Center The Maltings Stanstead Abbotts UK

5. Paul‐Ehrlich‐Institut Federal Institute for Vaccines and Biomedicines Langen Germany

6. European Medicines Agency Amsterdam The Netherlands

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

8. Medicines and Healthcare Products Regulatory Agency London UK

9. Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands

10. Legemiddelverket Oslo Norway

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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