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    Figure 1
    Acceptance of Real World Data (RWD) for the HTA process among selected European countries (Source: All figures were made by the author/IQVIA Consulting Services).

    Real World Evidence in Health Technology Assessments

    Fachthemen

    Real World Evidence offers valuable insights for research questions alongside RCTs
    HTA agencies across Europe base their decisions on RCT data
    The UK and the Netherlands accept RWE to demonstrate treatment effectiveness in the absence of RCTs
    In other European countries, RWD is only accepted as supportive evidence
    In France, RWD can positively influence the HTA decision making
    RCTs study duration falls short of long-term outcomes, a gap that RWD can close
    RCTs have often a highly limited external validity
    RWE is more likely to have a high bias potential but a larger population sample
    RWD are suitable to analyze patient characteristics and treatment options under real world conditions
    The combination of large data bases with advanced analytic techniques can be very powerful to detect benefits
    RWE can be generated retrospectively and prospectively. ?Pragmatic trialsʼ are most likely to be accepted RWE in the future
    Direct-to-patient data collection for HTA submissions
    RWD use a bigger patient sample size compared to RCT, while providing access to a wide array of information
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    Dirk Eheberg · IQVIA – Munich, Munich
    Dirk Eheberg
    holds a degree in biology from the University of Munich. After a few years working in basic research he started post-graduate studies in epidemiology and public health and completed his studies with a master degree in public health from the University of Munich (MPH). He gained experience in epidemiology, biometrics and working with SAS. Furthermore, he participated in special training programs for decision analytic modelling (decision analysis and Markov models in particular).
    At IQVIA, Dirk Eheberg works as Senior Project Manager and Strategy Lead. Since 2011 he focuses on benefit dossiers, especially on AMNOG dossiers
    (...)