European stakeholders' views on ethics aspects of patient registries: a survey study

Patient registry data are increasingly used to generate real-world evidence (RWE) for medicines decision-making. This study aimed to identify stakeholders' views on registries' ethics practices and to explore potential differences across stakeholder groups.

European regulators, Health Technology Assessors (HTA), payers, patients, academia, industry, and healthcare professionals (HCPs) were invited to complete an online survey (Dec 2024 - Jan 2025). It included questions regarding the importance of information on six ethics aspects of registries (5-point Likert scales), acceptability of industry funding for registries (visual analogue scale: 0-100%), and preferences on informed consent (opt-in versus opt-out), data identifiability (anonymous collection/processing; identifiable collection/pseudonymized processing; identifiable collection/processing) and data sharing (federated analyses; transfer of anonymous data; transfer of pseudonymous data; open access anonymous data). Results are reported as frequencies, means (M), and 95% confidence intervals (CI). Stakeholder group differences were tested using Fisher's exact, Kruskal-Wallis, and pairwise Dunn's tests.

There were 370 participants (129 regulators, 30 HTA/payers, 44 industry representatives, 39 patients, 128 academics/HCPs/others) from 31 countries, 56% were women, and on average 48 years old. Of the six ethics aspects, a registry's use-and-access policy was considered most important (M: 4.2; 95% CI: 4.1-4.3) and information on funding sources least important (M: 3.9; 95% CI: 3.8-4.0). Among the stakeholder groups, industry representatives considered the highest proportion of registry funding from the pharmaceutical industry acceptable (65%), while HTA/payers provided the lowest proportion (41%). Participants preferred patient opt-out over opt-in consent for data collection and processing by registries (51%) and for data processing by external parties (61%). Compared to all other stakeholder groups, patients more often preferred opt-in consent for both types of data processing (76% and 73%, respectively). Collecting identifiable data and processing pseudonymized data was most preferred overall (65%), while regulators and patients more often favored anonymization than other stakeholders (respectively 34% and 35% versus ≤18%). Overall, anonymization was preferred for data sharing with external parties (34%).

Participants generally viewed information on patient registries' ethics aspects as important. There was a preference for pseudonymization of data used by registries and anonymization of data shared with external parties. Across stakeholder groups, preferences diverged most notably regarding industry funding and consent models. These differences will have to be addressed to work towards a multi-stakeholder consensus on patient registries' best practices.