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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)
RWD Informs Choice of Endpoints & How Such Endpoints Become Part of Clinical Development Plan
Somnath Sarkar, PhD
Flatiron Health, United States
VP, Head of Quantitative Sciences
Accelerating Clinical Research by Unleashing the Power of Real-World Data at Scale
Rachael Higgins
Trinetx, United States
VP Account Management
Observational Study to Strengthen the Evidence Collected in a Phase III Program
Elina Asikanius
Finnish Medecines Agency Fimea, Finland
Biostatistician
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