ISSUE: There has been a sustained growth of real-world data (RWD) sources for research purposes that has contributed to the increased openness to RWE studies in regulatory and HTA decision-making; however, the logistical and financial costs needed to generate high-quality RWE from these sources hampers the availability of RWE for decision-making. Although the responsibility in certain situations (such as in post-authorization safety studies) clearly falls on the manufacturers, it is currently not clear who should be responsible in other scenarios (e.g., filling evidence gaps needed by payers post-launch). This session will provide a forum to debate, from a variety of different perspectives, whose responsibility it is to generate RWE to address evidence gaps, and to discuss potential mechanisms to foster constructive dialogue between stakeholders when determining this responsibility.

OVERVIEW: The moderator will provide an overview of the stakeholders, different scenarios of when ownership of RWE generation is unclear, and challenges associated with RWE generation (10 minutes). The diverse panelists will then present their perspective on when key stakeholders should and/or should not be responsible for RWE generation (10 minutes each). The panels will also discuss ideas and incentives for collaboration among stakeholders to address evidence gaps. The moderator will then oversee a debate between the panelists and incorporate questions/comments from the audience (20 minutes). Stakeholders (regulators, researchers, industry, HTA bodies/payers, patient advocates, etc) interested in using RWE for decision-making will benefit from attending.