P315: Perceptions of Integrating Patient Preference Information into Regulatory Decision-Making: A Multi-Stakeholder Survey
Poster Presenter
Eui-Kyung Lee
Professor, School of Pharmacy
SKKU (sungkyunkwan University) Korea, Republic of
Objectives
This study aimed to examine stakeholder perceptions regarding the necessity and current incorporation of patient preference information (PPI) into regulatory decision-making and to identify priority application domains and key requirements for its effective integration.
Method
We conducted an online survey (August 18–31, 2025) of industry, academia, patient organizations, and regulatory agencies. Paired t-tests compared necessity vs current incorporation. One-way ANOVA with post hoc tests assessed stakeholder-group differences; partial ?² quantified effect size.
Results
A total of 183 stakeholders participated. Across all stages of the medical product life cycle, the perceived necessity ratings of incorporating patient experience data (PED), including PPI, were significantly higher than the current policy incorporation (all p < 0.001), with a mean gap of 1.17 on a 5-point scale.
Between-group differences in perceived necessity of PPI were substantial (overall partial ?² = 0.147), with the largest divergence observed at the approval stage (partial ?² = 0.191). Patient organizations consistently reported higher necessity ratings, whereas industry stakeholders—particularly medical device and pharmaceutical companies—reported lower ratings at the approval stage. Perceived necessity was highest in the post-marketing stage (mean = 4.06).
Regarding patient preference–sensitive priority areas, necessity ratings were highest when direct patient operation or use of a product was required (4.14) and lowest when evidence on efficacy or safety was uncertain (3.42). Between-group differences were substantial (overall partial ?² = 0.135).
In terms of submission level, most stakeholders favored recommending PPI submission for preference-priority products (41.7%), whereas patient organizations more frequently supported mandatory submission (46.9%). Key perceived barriers included lack of standardized PPI measurement methods (4.03) and insufficient institutional frameworks (4.01). Regulator-led guidance (4.25) and clear identification of priority areas (4.20) were considered essential readiness requirements for institutional integration.
Conclusion
A consistent gap between the perceived necessity of PED, including PPI, and its actual policy incorporation indicates that patient input remains insufficiently institutionalized in regulatory decision-making. Substantial differences across stakeholder groups—particularly at the approval stage—highlight divergent expectations regarding the role of PPI. Stakeholders perceived PPI as most appropriate in contexts closely linked to patient use, while viewing it as complementary rather than substitutive to traditional efficacy and safety evidence. Clear priority areas, standardized methodologies, and regulator-led guidance are essential to enable structured and sustainable integration of PPI into regulatory frameworks.
