Stakeholders' Perspectives on the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey

OBJECTIVES: To identify European stakeholders’ perspectives regarding registry data in regulatory and Health Technology Assessment (HTA)/payer applications, and explore factors influencing respondents’ intention to use registry data for future decision making.

METHODS: European regulators, HTAs, payers, and other stakeholders (industry, academia, healthcare providers, patient representatives) were invited by email to participate in this web-based survey study. The 24-question survey was open between Nov 2023 and Jan 2024 and included demographics and registry questions. The latter consisted of 5-point Likert scales questions about factors of the theory of planned behavior, i.e., attitudes, subjective norm, perceived behavioral control, and intention. Descriptive and regression analyses (outcome: intention; predictors: demographics and other factors of the theory) were performed.

RESULTS: Included were 191 responders (16% response rate; 110 regulators, 24 HTAs/payers, 57 other stakeholders). Most respondents were between 41-50 years, 53% had >10 years work experience, 65% were women. From several scenarios, respondents considered ‘characterization of disease epidemiology’ most informative (mean 4.4; 95%-CI: 4.2–4.5), comparative effectiveness least (mean 3.6; 95%-CI: 3.4–3.7). Respondents perceived reaching the relevant patient population as the biggest strength (mean 3.6; 95%-CI: 3.4–3.8), data quality as least strength (mean 2.4; 95%-CI: 2.2–2.6). The intention to use registry data in the future was higher among other stakeholders than among regulators or HTAs/payers (β 2.53; p 0.00004). Northern European respondents had a lower intention to use registry data in the future (β -1.74; p 0.043), whereas a positive attitude (β 0.76; p 0.058) and high behavioral control (β 1.25; p 0.017) regarding the use of registry data were associated with an higher intention.

CONCLUSIONS: Stakeholders are open to increase the use of registry data to inform decision making. Some applications were identified for which stakeholders considered registry data to be more informative than for others. Regulators and HTAs/payers are generally aligned in their perspectives.