Bridging the Gap or Respecting the Divide? Discussing the Integration of Clinical Outcome Assessments and Patient Preference Data
Moderator
Shelby Reed, RPh, PhD, Duke Clinical Research Institute, Durham, NC, United States
Speakers
Karen V. MacDonald, BSc, MPH, IQVIA Canada, Calgary, Canada; Juan M Gonzalez, PhD, Duke Clinical Research Institute, Cary, NC, United States; Mo Zhou, PhD, Novartis, East Hanover, NJ, United States
There is growing recognition that integrating COAs with PPI can enrich our understanding of patient well-being. However, meaningful integration remains challenging due to differences in assumptions, measurement paradigms, and intended uses. Although these approaches stem from distinct traditions, combining them offers unique insights that neither can provide alone.
Opportunities span clinical care, regulatory review, and HTA. For instance, clinicians can align treatment decisions with patient concerns by comparing expected outcomes and stated concerns. PPI also can help identify relevant domains for COA development and guide COA selection when multiple options exist. In regulatory reviews, COA-based benefits can be interpreted alongside patient tradeoffs, informing what constitutes a meaningful benefit. In HTA, incorporating preference heterogeneity into COA interpretations can inform anticipated treatment uptake, usage intensity, and real coverage costs.
Despite these opportunities, substantial challenges persist. Key barriers include limited cross-disciplinary understanding, differing objectives for COA and PPI instruments, and lack of guidance on how COA and PPI data could be combined to maximize their impact. A candid discussion about when full integration adds value, and when coordinated but parallel use is more practical, is critical for advancing patient-centered evidence generation.
Panelists will reflect on methodological considerations, potential value, and practical strategies for leveraging these complementary approaches to support more holistic and equitable decision making in clinical, regulatory, and coverage contexts. The panel will also consider when such integration provides insights that justify added complexity and investments, and which areas of complementarity, such as defining clinical care, contextualizing benefit-risk assessments, or supporting health technology assessments, should be prioritized.
Each panelist will offer a 10-minute perspective, followed by moderated discussion and audience engagement.
Topic
Clinical Outcomes, Patient-Centered Research