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Smarter Clinical Trials with Real World Evidence Data
Session Chair(s)
Holger Maria Rohde, PHD, MBA, MSC
Director Regulatory Project Management, Merck KGaA, Germany
In the session we will discuss innovative ways to leverage RWD/RWE to optimise clinical trial design, such as the fine-tuning of a targeted population, improvement of site selection and patient recruitment, but also to complement traditional development in changing (or increasing?) regulatory requirements. How can we increase efficiency of clinical trial design, mitigate against avoidable delays and costs, and unlock advanced “what if” scenario planning options in the trial design process? What kind of data and design can complement evidence from clinical trials, in which situations this could be helpful to fulfil regulatory requirements?
Learning Objective : Understand how longitudinal and non-longitudinal data sources currently available globally can inform study design, target product profile, and clinical development plan.
Speaker(s)
Patrice Verpillat, DrMed, MD, PHD, MPH
Head of Real World Evidence, European Medicines Agency, Netherlands
Will RWE Replace Evidence Coming from Clinical Trials in the Future?
Michel Francois Denarie, MBA
Senior Principal, Regulatory Affairs and Drug Development Solutions, IQVIA, United States
How Can Real World Data Improve the Early Clinical Development Process?
Aldana Mariela Rosso, PHD
Senior Adviser Biostatistics, Danish Medicines Agency (DKMA), Denmark
The Role of Real World Data in the Regulatory Setting
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