ISSUE: While regulatory and health technology assessment (HTA) agencies are proactively evaluating the role of RWE in their decision-making, they are at different stages of guidance development and adoption. Their common goal is to promote high-quality RWE generation and articulate how RWE will be used in their decision-making. However, no one-size-fits-all approach to RWE generation exists; regulatory and HTA agencies have different evidence needs, different opinions on what elements are essential, and different perspectives on how RWE can inform decisions. These differences will drive the panel debate on what RWE study design and methodology is necessary for regulatory and HTA guidelines to promote high-quality and validated RWE. The panel will also discuss how manufacturers can meet disparate evidence requirements.

OVERVIEW: The moderator will present an overview of current RWE guidance from stakeholder groups, regulatory, and HTA agencies noting the similarities/differences in design and application (10 minutes). Panelists from regulatory, HTA, and industry will each deliberate on the merits and challenges of the guidances (10 minutes each). The moderator will then facilitate a debate on how the guidences impacts industry’s evidence development and what elements are most effective in promoting high-quality, transparent, and validated RWE. Stakeholders from industry, especially those generating RWE, and regulatory and HTA agencies should attend.