Folding Patient Experience into EU Real-World Data Studies

May 10, 2023

The use of real-world data (RWD) and real-world evidence (RWE) into clinical research and regulatory decision making is growing in the EU. However, patient experience data is yet to be incorporated, for a variety of reasons. The European Medicines Agency (EMA) held a panel last year to discuss patient experience data and best practices by which it can be leveraged going forward.

According to Julia Lakeland, “One reason often outlined as to why patient experience data is not actively included in medicines development is because of a belief that the data will not be accepted by regulators, or is not considered of value in their decision making. There is a recognized need for further guidance from regulators on what criteria and minimum patient experience data is required for regulatory decision-making, and ultimately to ensure medicines are fit-for-purpose. EU regulators have said that they actively welcome patient insights, namely COAs (PerfOs, ClinROs, and ObsROs) as part of medicines development, and agree that this type of information should be part of marketing authorization applications. In support of this movement, FDA published a report in June 2021 which revealed that of the 176 approved new medicines (NDAs and BLAs) granted between June 2017 and June 2020, 30% mentioned patient experience data in the labelling, with COAs accounting for 92% of that data.”

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