Dr. Miguel Ángel Mayer, a prominent physician at Hospital del Mar and director of Center Management, has been a key figure in the development of a new report on Real World Data (RWD) and Real World Evidence (RWE). This report, published by the Council for International Organizations of Medical Sciences (CIOMS), aims to guide regulators and health policy makers in the integration of these data for decision-making on the effectiveness of treatments and medications.
CIOMS, an entity founded by the World Health Organization and UNESCO, works to advance public health through guidelines on research and health regulations. The document titled “Real-world data and real-world evidence in regulatory decision-making” seeks to establish a global consensus that facilitates the harmonization of regulatory standards and definitions. It also specifies the necessary requirements to validate the effectiveness of medications, integrating RWD and RWE throughout the life cycle of a medical product.
One of the most notable innovations of the report is the development of ethical guidelines that ensure the appropriate and effective use of real-world data. Dr. Mayer’s participation highlights the importance of his contribution in an emerging area of medical research, where evidence derived from clinical practice can be as significant as that from traditional clinical trials. The report promises to be an invaluable resource for healthcare professionals and regulators, contributing to the search for safer and more effective treatments.
via: MiMub in Spanish
