Session (CTI)

Issue: Effective and timely decision-making in healthcare depends on reliable, comparable data, especially with increasing resource demands. Core Outcome Sets (COS) standardize outcome selection and measurement through a multi-stakeholder approach, which increasingly includes patients. Thus, COS could serve as an important link between clinical trials, regulatory processes and Health Technology Assessment (HTA) regulations. Ultimately, COS can guide decision-makers, including patients and the public. However, COS development and uptake can differ across disease areas and environments, creating variability in their usage settings and impact. This panel will cover: 1) COS as a multi-stakeholder tool, for identifying outcomes that matter to those most impacted (i.e. patients);  2) COS as way to standardize outcome measurement, allowing for potential cross-trial comparisons and system-wide efficiencies;  3) Incorporating COS into endpoint strategies and value propositions; 4) Using COS for reimbursement decisions and clinical guideline development. Overview: The session will explore COS development, adoption, and application across a range of settings and diseases, their role in clinical research, and potential effects on HTA and decision-making. The panel will examine future prospects and potential for COS usage. Paula Williamson will provide an overview of COS development, uptake, and usage, highlighting opportunities, challenges and growth areas (15 minutes).  Justin Doan will discuss the need for wider dialogue and collaboration among sponsors, regulators, and payers to ensure alignment on using COS in designing endpoint strategies and capturing treatment impacts without leaving value behind (15 minutes). Nichole Taske will discuss the influence of COS from the payer perspective and will reflect on the opportunities for standardized outcome measurement across the HTA and clinical guideline evidence lifecycle (10 minutes). The panel discussion, moderated by Alice Biggane, will feature perspectives from academia, industry, and a HTA and guideline producing body. Alice will facilitate audience questions (20 minutes).