Sep 3, 2015
IQWiG invites to its Autumn Symposium 2015
Real-world data for benefit assessments: How can registries and routine data contribute?
Benefit assessments of medical interventions are conducted to answer the question: What is the benefit and possible harm of the intervention for patients? It has been repeatedly demanded to use not only the results from “artificial” randomized controlled trials to answer this question, but also data from the actual health care setting (real world). This raises some obvious questions: What are the characteristics of these data and what specific contribution could they make to benefit assessments? What requirements would they have to meet to provide a basis for valid conclusions? Is it acceptable to accelerate drug approval on the basis of a weaker evidence base, referring to later real-world data?
This year’s Autumn Symposium will focus on these questions: International and national experts from research and the health care systems will present their answers to these questions for discussion.
Are real-world data an asset for benefit assessments?
On 27 November, Matthias Augustin from the University Medical Centre Hamburg-Eppendorf addresses the fundamental question: Do we need real-world data for benefit assessments? Monika Klinkhammer-Schalke from the Regensburg Tumour Centre and Rolf Lefering from Witten/Herdecke University take a closer look at different registry data. Thomas Mansky from the Technical University of Berlin presents possibilities and pitfalls when using routine data for benefit assessments. Gerd Antes from the German Cochrane Centre questions the concept underlying the call for real – or even big – data.
On the second day, 28 November, Hans-Georg Eichler from EMA presents the “adaptive pathways” approach. Elisabeth George from NICE describes whether routine data can compensate for insufficient evidence. Dieter Paar from Sanofi-Aventis sees earlier drug approval as an opportunity for patients, whereas Bernd Mühlbauer from the Bremen Mitte Hospital, member of the Board of Directors of the Drug Commission of the German Medical Association, addresses its risks for patients.
People who would like to participate in this event can register up to 6 November 2015. Prior registration is required for this Event.