2017/November - 2nd KCE Trials symposium: Real-world evidence: randomised trials in daily practice




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 Healthdata.be 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, Belgian and international speakers share their experience and views.


9.20 Welcome   Christian Leonard, Deputy General Director, KCE (BE)
9.30 Welcome   Maggie De Block, Minister of Social Affairs
  and Public Health (BE)
9.40 Slides: Introduction to pragmatic trials including cluster randomised trials and stepped wedge design   Sandra Eldridge, Barts and The London School
  of Medicine and Dentistry (UK)
10.10 Slides: Update on KCE Trials and the BeNeLux call   Frank Hulstaert, KCE (BE)
10.35 Slides: Hands on experience with registry-based randomised trials and how you can make it work   Jonas Oldgren, Uppsala Clinical Research Center
11.05-11.45 BREAK
11.45 Slides: Centralised ICT support for registries and trials in Belgium   Jan Kips, Healthdata.be (BE)
12.05 Slides: Low intervention trials and registry-based randomised trials, the regulatory perspective   Greet Musch, Federal Agency for Medicines
  and Health Products (BE)
12.25-13.30 SANDWICH LUNCH
13.30 Slides: Pragmatic trials, ethics and informed consent considerations   Shona Kalkman, University Medical Center Utrecht (NL)
14.00 Slides: Which outcomes are important to patients: the Core Outcome Measures in Effectiveness Trials
(COMET) initiative
  Paula Williamson, University of Liverpool (UK)
14.30 Slides: How to define a clinically relevant difference: the DELTA (Difference ELicitation in TriAls) project   Jonathan Cook, University of Oxford (UK)
15.00 A clinical trials management system (CTMS) for hospitals   France Vrijens, KCE (BE)
15.05 Closure   Frank Hulstaert, KCE (BE)
KCE Trials (NL/FR/EN)
+32 2 287 33 88
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