Last updated: OCT 23, 2025
Real-world Data Holds the Power to Impact Patient Outcomes
According to an article in Global Forum, published by the industry organization Drug Information Association (DIA), over half of all U.S. Food and Drug Administration (FDA) submissions approved for new drugs and biologics in 2019 included a real-world evidence (RWE) study. In 2020, that figure jumped to 78%. In Europe, RWE was used in 40% of marketing authorization applications and 18% of indication extensions that were submitted to the European Medicines Agency (EMA) in 2018-2019.1 And in Japan, some orphan drugs have already been based on the assessment of real-world data (RWD).
The FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records (EHRs), medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.” Although the two are interrelated, RWD should not be confused with RWE, which the FDA defines as “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.”
To promote progress in the field, the FDA has issued a series of draft guidances on aspects of both RWD and RWE in regulatory decisionmaking. This series includes many aspects of RWD, including: EHRs and medical claims, clinical trial registries, data standards and regulatory considerations. The DIA notes that work towards global convergence on RWD policies and standards is being done through the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Coalition of Medicines Regulatory Authorities, and the Council for International Organizations of Medical Sciences.
A report by the EMA and Heads of Medicines Agencies (HMA) reviewed the value of RWD studies conducted between September 2021 and February 2023 aimed at addressing needs of EU regulators and external stakeholders including health technology assessment (HTA) bodies and payers’ organizations. The EMA and the European Medicines Regulatory Network (EMRN) are working on a framework to better integrate RWD/RWE alongside the gold standard of randomized controlled trials into regulatory decisions on the development, authorization, and supervision of medicines. Learnings and recommendations from the review included the following:
Download the article for more
