Program

INVITED SESSION 7: Regulators’ View of Randomised and Non-Randomised Evidence in Drug Development

Tracks

PLENARY HALL (Friends of Music))

Wednesday, July 24, 2024

2:00 PM - 3:36 PM

PLENARY HALL (M1 building upper floor)

Details

The term “real-world evidence” is commonly used to refer to non-randomised evidence generated from the analysis of data routinely collected in the delivery of health care. This session brings together speakers from the FDA, EMA, academia, and industry to discuss the appropriateness of using non-randomised evidence where randomised evidence could have been collected and used instead in the assessment of the efficacy and safety of treatments with a particular focus on drug development.

Presentations

Sir Richard Peto

University of Oxford, Nuffield Department of Population Health

IS7-1 | The magic of randomisation versus the myth of Real-World Evidence

2:00 PM - 2:15 PM

Presentation Abstract:

Dr. John Concato

Center for Drug Evaluation & Research, Food and Drug Administration (FDA)

IS7-2 | FDA and Real-World Evidence

2:15 PM - 2:35 PM

Presentation Abstract:

Dr. Andrew Thomson

European Medicines Agency (EMA)

IS7-3 | Use of Real-World Evidence in EU regulatory decision making

2:35 PM - 2:55 PM

Presentation Abstract:

Dr. Adrian Mander

GlaxoSmithKline, Dept of Statistical Innovation for SPC

IS7-4 | The use of Real-World Evidence within the context of Open-Label Extensions

2:55 PM - 3:10 PM

Presentation Abstract:

Prof. James D. Neaton

University of Minnesota, School of Public Health, Division of Biostatistics & Health Data Science

Discussant

3:10 PM - 3:20 PM

Round Table Discussion

3:20 PM - 3:30 PM

Chair

Αbdel Babiker

Professor of Medical Statistics & Epidemiology

University College London, United Kingdom

Giota Touloumi

National & Kapodistrian University of Athens, School of Medicine, Dept of Hygiene, Epidemiology & Medical Statistics