In developing its RWE program, FDA believes it is helpful to distinguish between the sources of RWD and the evidence derived from that data. Evaluating RWE in the context of regulatory decision-making depends not only on the evaluation of the methodologies used to generate the evidence but also on the reliability and relevance of the […]

All ICER reports of pharmaceuticals published between January 2014 and June 2019 were reviewed for the average number of instances and proportion of real-world evidence used in the scoping documents. In the ICER scoping documents, the mean number of instances of real-world evidence use was 3.8 per document.   “There has been growing interest in […]

Takeda presented nine abstracts at the 62nd ASH Annual Meeting & Exposition, all utilising real-world evidence from the treatment of haemophilia, von Willebrand disease and sickle cell disease Takeda are using real-world evidence (RWE) from studies across rare bleeding disorders to demonstrate the crucial role understanding patterns of care play outside of clinical studies play in […]

Guidance issued for Sponsors planning to conduct clinical research to support regulatory decisions Use of RWE has the potential for increasing the speed and reducing the cost of development programmes, which would see effective medications being approved more quickly The MHRA encourages Sponsors to explore the opportunities presented by the utilisation of RWE RWE just […]