Expanded Access Programs (EAPs) provide sponsors the opportunity to collect meaningful Real World Data (RWD), i.e. data on health care that is derived from multiple sources outside of the typical clinical research settings.
More and more, regulatory bodies around the world, like the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA), etc. are encouraging companies to collect RWD, if and when appropriate. These regulators recognize the tremendous value in collecting data in the real world setting and using it to better inform stakeholders and promote safe and effective use of products, quicker, for patients in need.
WEP Clinical has developed some slides to help companies better understand RWD collection in the expanded access space.