Real World Data (RWD) is data relating to patient health status and/or the delivery of routine healthcare and is collected from a variety of sources, such as electronic health records (EHRs) and disease registries.
RWD can provide opportunities in research, such as supporting clinical trial design and developing more effective interventions.
The Human Medicines Regulations 2012 has been amended via the Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 to include specific provisions for the Early Access to Medicines Scheme (EAMS).
The provisions create a supporting framework for the collection of RWD which allows for the collection of such data without the need for a clinical trial approval (where the Medicines and Healthcare products Regulatory Agency (MHRA) has no concerns about the collection of that data).
The collection of RWD under the EAMS should be in relation to the clinical management of patients receiving the medicinal product. Therefore it must not be to answer a research question under a protocol. However, whilst the collection of RWD under the scheme is not for the purpose of research, it is recognised that data may have research value once collected. Where it is possible that data which is being collected may be used for the purpose of research, this should be addressed as part of the consent process.
Patients consenting to the collection of their data under the scheme should additionally be provided with information about the potential for future research use and asked whether they consent to their data being used for such purposes.
If you are planning to collect RWD under the EAMS and/or you have collected RWD which you would like to use for research purposes, please contact queries@hra.nhs.uk.