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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)
Will RWE Replace Evidence Coming from Clinical Trials in the Future?
Patrice Verpillat, DrMed, MD, PHD, MPH
European Medicines Agency, Netherlands
Head of Real World Evidence
How Can Real World Data Improve the Early Clinical Development Process?
Michel Francois Denarie, MBA
IQVIA, United States
Senior Principal, Regulatory Affairs and Drug Development Solutions
The Role of Real World Data in the Regulatory Setting
Aldana Mariela Rosso, PHD
Danish Medicines Agency (DKMA), Denmark
Senior Adviser Biostatistics