Real-World Evidence Tag

  • The use of Real-World Data (RWD) is increasingly embedded in the scientific evaluation of human medicines.The newly published EMA document on the topic (Guidance on┬áReal-world evidence provided by EMA), explains:
    • how RWE, derived from analysis of RWD, can be useful in the context of regulatory decision-making,
    • what types of studies can be conducted,
    • how the EMA can help identify the best resources to address a research question.


    An analysis of the RWD provided by the EMA could help

    • to fill knowledge gaps;
    • to provide independent and transparent RWE sources;
    • to carry out specific analyses tailored to the individual case, e.g. to support the work of EMA’s scientific committees;
    • generate evidence more quickly, shortening the process steps that an MAH would have to comply with to obtain the corresponding study approved;
    • avoid unnecessary duplication and inefficiency that might be typical of studies done by industry.

    An overview of the three main areas in which RWE can support regulatory decision-making is shown in the figure below (taken from the document).


    EMA’s Big data website.