Real-world evidence (RWE) informs decisions that impact clinical trial planning and patients’ access to medicines by providing insight into outcomes across a broad range of patients and settings. However, numerous considerations when planning real-world studies can present a challenge to researchers.

The RWE Framework is a novel visual study design tool developed and pilot tested by researchers in RWE from the pharmaceutical industry. This concise, easy-to-follow, step-wise, interactive aid informs the design of a broad range of real-world study types from non-interventional retrospective or prospective studies to interventional pragmatic trials.

Given a search of published literature and web-based sources identified lack of concise visual tools to inform the design of real-world studies, the RWE Framework has potential to enhance decision-making when planning real-world studies and facilitate team discussion.