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Quality criteria for Real-World Data in pharmaceutical research and healthcare decision making. An Austrian Expert Consensus.
Peter Klimek;
Dejan Baltic;
Martin Brunner;
Alexander Degelsegger-Marquez;
Gerhard Garhöfer;
Ghazaleh Gouya-Lechner;
Arnold Herzog;
Bernd Jilma;
Stefan Kähler;
Veronika Mikl;
Bernhard Mraz;
Herwig Ostermann;
Claas Röhl;
Robert Scharinger;
Tanja Stamm;
Michael Strassnig;
Christa Wirthumer-Hoche;
Johannes Pleiner-Duxneuner
ABSTRACT
Real-world data (RWD) collected in routine healthcare processes and transformed to real-world evidence (RWE) has become increasingly interesting within research and medical communities to enhance medical research and support regulatory decision making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which quality RWD must meet in order to be acceptable for decision making within regulatory or routine clinical decision support. An Austrian expert group led by GPMed (Gesellschaft für Pharmazeutische Medizin, Austrian Society for Pharmaceutical Medicine) reviewed drafted guidelines, published recommendations or viewpoints to derive a consensus statement on quality criteria for RWD to be used more effectively for medical research purposes beyond registry-based studies discussed in the European Medicines Agency (EMA) guideline for registry-based studies
Citation
Please cite as:
Klimek P, Baltic D, Brunner M, Degelsegger-Marquez A, Garhöfer G, Gouya-Lechner G, Herzog A, Jilma B, Kähler S, Mikl V, Mraz B, Ostermann H, Röhl C, Scharinger R, Stamm T, Strassnig M, Wirthumer-Hoche C, Pleiner-Duxneuner J
Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus