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Session 5: Adopting RWE to Fine-Tune the Design and Efficiency of Randomised Clinical Trials
Session Chair(s)
Michael Seewald
Head Real World Evidence, Novartis Pharma AG, Switzerland
Solène Thieffry, MSC
Global RWE Policy Lead, UCB, Belgium
Real-world data has the potential to play a major role in RCT design to inform decisions on key protocol components such as inclusion criteria, comparators and endpoints. This session will provide with use cases on RCTs enhancement and discuss on acceptability from different stakeholders in these new approaches. In addition, the rise of RWD allows to advance efficiency of RCT such as site selection and patient recruitment. Different examples will be discussed on how RWE can improve RCTs execution.
Speaker(s)
Somnath Sarkar, PHD
VP, Head of Quantitative Sciences , Flatiron Health, United States
RWD Informs Choice of Endpoints & How Such Endpoints Become Part of Clinical Development Plan
Rachael Higgins
VP Account Management, Trinetx, United States
Accelerating Clinical Research by Unleashing the Power of Real-World Data at Scale
Elina Asikanius
Biostatistician, Finnish Medecines Agency Fimea, Finland
Observational Study to Strengthen the Evidence Collected in a Phase III Program
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