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Swissôtel Le Plaza

Oct 24, 2019 9:00 AM - Oct 25, 2019 5:30 PM

Messeplatz 25, 4005 Basel, Switzerland

Future of Evidence Workshop

RWE and RCT as building blocks for transformative evidence generation

Session 5: Adopting RWE to Fine-Tune the Design and Efficiency of Randomised Clinical Trials

Session Chair(s)

Michael  Seewald

Michael Seewald

Head Real World Evidence

Novartis Pharma AG, Switzerland

Solène  Thieffry, MSc

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.


Somnath  Sarkar, PhD

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

Rachael  Higgins

Accelerating Clinical Research by Unleashing the Power of Real-World Data at Scale

Rachael Higgins

Trinetx, United States

VP Account Management

Elina  Asikanius

Observational Study to Strengthen the Evidence Collected in a Phase III Program

Elina Asikanius

Finnish Medecines Agency Fimea, Finland


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