8.4 Real-life data and learning from practice to advance innovation
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چکیده
The costs of pharmaceutical R&D are high, with clinical trials being a major component of these development costs. At the same time, there is an urgent need to address therapeutic gaps in order to be able to respond to unmet medical needs. To help resolve this problem, there is a need to increase efficiency and to bridge bench and clinical research with real-world practice. Data obtained from health information systems can be used to support innovation, detect safety problems and assess the realworld effectiveness of medicines. These data are now more widely available than ever before and offer new opportunities for research and health systems development. Policy initiatives such as adaptive licensing, value-based pricing and comparative effectiveness studies are critically dependent on the efficient use of electronic health record (EHR) data. However, the resources available in Europe are fragmented, and good quality data are often only available for limited disease areas or geographic regions.
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