EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else.

Patients’ perspectives on medicines and their benefits and risks are of great value to EMA. Patient experience data provide medicines regulators and other decision-makers in healthcare systems with valuable insights into what matters most to patients, beyond other well-established scientific outcomes. An example of the value of these data are cancer medicines where patients may, in some cases, prioritise quality of life over traditional clinical endpoints like overall survival. As such, patients’ lived experiences, reflected in quantitative or qualitative patient experience data, can play a complementary role to other types of data currently collected, notably through clinical trials, and further inform regulator’s…