Real-world evidence: randomised trials in daily practice - 2nd KCE Trials symposium

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SAVE THE DATE: 28 November 2017 (9:00-15:00)— Pacheco Centre Brussels

KCE Trials selects and funds randomised trials on medical interventions in real life, called pragmatic practice-oriented trials.
But how to design such trials? What are the challenges to conduct them and why are they important for healthcare policy decisions? What are registry-based randomised trials?  How can ICT support from facilitate pragmatic trials in Belgium? What is the regulators’ point of view? How do I design a pragmatic trial in terms of outcomes and how do I define a clinically relevant difference? Are there any ethical issues and what about informed consent?

In the 2nd  KCE Trials symposium, the following Belgian and international speakers share their experience and views. Each presentation will be followed by a Q&A session.

Welcome and introduction by Maggie De Block, Minister of Social Affairs
and Public Health, and Raf Mertens, General Director of KCE

Confirmed speakers:


Sandra Eldridge
Barts and The London School of Medicine and Dentistry, UK

Introduction to pragmatic trials including cluster randomised trials and stepped wedge design

Greet Musch
Federal Agency for medicines and health products, Belgium

Low intervention trials and registry-based randomised trials, the regulatory perspective

Frank Hulstaert
KCE, Belgium

Update on KCE Trials and the BeNeLux call

Shona Kalkman
University of Utrecht, the Netherlands

Pragmatic trials, ethics and informed consent considerations

Jonas Oldgren
Uppsala Clinical Research Center, Sweden

Hands on experience with registry-based randomised trials, how can you make it work

Jonathan Cook
University of Oxford, UK

How to define a clinically relevant difference: the DELTA (Difference ELicitation in TriAls) project 

Johan Van Bussel, Belgium

Centralised ICT support for registries and trials in Belgium

Paula Williamson
University of Liverpool, UK

Which outcomes are important to patients: the Core Outcome Measures in Effectiveness Trials (COMET) initiative


  • More details on the time schedule will follow
  • All presentations will be in English, without  simultaneous translation
  • Accreditation has been requested
  • Attendance is free, but prior registration is required.


KCE Trials
+32 2 287 33 88
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