The aim of this paper is to describe an interactive Decision Aid designed to:

Serve as a tool for researchers, industry, and other stakeholders to identify areas of opportunity for real-world evidence (RWE) to support regulatory strategies and clinical development plans.

Illustrate key uses of RWE for regulatory purposes (by utilizing precedent cases where RWE was successfully used to support regulatory decisions), corresponding RWE study designs, and underlying key success factors.

Encourage further use of RWE and activity in this space to add to the growing evidence and establishment of RWE in regulatory submissions.

This manuscript and associated Decision Aid are intended to help researchers identify potential use cases in which RWE might be considered to inform regulatory decision-making.