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UNSTRUCTURED Real-world data (RWD) collected in routine health care processes and transformed to real-world evidence have become increasingly interesting within the 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 qualities RWD must meet in order to be acceptable for decision-making within regulatory or routine clinical decision support. In the absence of guidelines defining the quality standards for RWD, an overview and first recommendations for quality criteria for RWD in pharmaceutical research and health care decision-making is needed in Austria. An Austrian multistakeholder expert group led by Gesellschaft für Pharmazeutische Medizin (Austrian Society for Pharmaceutical Medicine) met regularly; reviewed and discussed guidelines, frameworks, use cases, or viewpoints; and agreed unanimously on a set of quality criteria for RWD. This consensus statement was derived from the quality criteria for RWD to be used more effectively for medical research purposes beyond the registry-based studies discussed in the European Medicines Agency guideline for registry-based studies. This paper summarizes the recommendations for the quality criteria of RWD, which represents a minimum set of requirements. In order to future-proof registry-based studies, RWD should follow high-quality standards and be subjected to the quality assurance measures needed to underpin data quality. Furthermore, specific RWD quality aspects for individual use cases (eg, medical or pharmacoeconomic research), market authorization processes, or postmarket authorization phases have yet to be elaborated.

The role of drug regulatory agencies is to protect and promote public health. In everyday practice, this broad mandate translates into two distinct objectives: first, into an obligation to protect patients against ineffective or harmful drugs and, second, to protect patients against the consequences of untreated disease. The first objective results in a gatekeeper function and obliges regulators to apply stringent standards of assessment and to deny marketing authorisation where deemed necessary. By contrast, the second objective requires regulators to support and enable drug development – with a view to ensuring that patients have access as early as possible to safe and effective drugs.

Organic nitrates exert well known vasodilating effects in coronary arteries, although the exact mechanism of action is not fully understood. In this study the influence of these drugs on the biosynthesis of eicosanoids from labelled exogenous arachidonic acid (AA) in isolated platelets was examined. Platelet malondialdehyde (MDA)-formation in the presence of the substances tested in this system was studied too. The vasodilating drugs were found to reduce the conversion rate to TxB 2 , hydroxy- 5,8,10-heptadecatrienoic acid (HHT) and MDA in platelets dose-dependently. Isosorbid-5-mononitrate (ISMN), nitroglycerin (NG) and SIN 1, the active metabolite of molsidomin, showed their inhibitory effects at concentrations of about 1mM, isosorbid-dinitrate (ISDN) had a much weaker effect on platelet-biosynthesis - a concentration of about 3mM was necessary to inhibit TxB 2 -formation significantly.