HMRI Press 22/08/2024
The Council for International Organizations of Medical Sciences, an entity created by the World Health Organization and UNESCO to help advance public health through guidance on research and health policies, has published the report Real-world data and real-world evidence in regulatory decision’, in which Dr. Miguel Ángel Mayer, from the Management Control department of Hospital del Mar and its research institute, has participated.
The report aims to provide a universal consensus document that can be used to facilitate the harmonization of regulatory standards and definitions, articulate the requirements to support the determination of drug efficacy, and help develop a set of ethical guidelines for real-world data (RWD) and real-world evidence (RWE) by expanding the use of RWD/RWE for decision-making throughout the entire lifecycle of medical products.
You can read the article here