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Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications
Session Chair(s)
Francesco Pignatti, MD
Scientific Adviser for Oncology
European Medicines Agency, Netherlands
Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.
Learning Objective : Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.
Speaker(s)
Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
Douwe Postmus, PhD, MSc
University Medical Center Groningen & EMA, Netherlands
Assistant Professor & Seconded National Expert
External Comparators Using Real-World Data: Results of a Simulation Study
Gerd Rippin, DrSc
IQVIA, Germany
Senior Director, Biostatistics, Real-World Solutions
The Role and Impact of Real-World Data in Cancer Drug Applications
Catherine Lerro, PhD, MPH
FDA, United States
Senior Pharmacoepidemiologist, Oncology Center of Excellence
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