Swimming in the Sea of RWE Guidance: Debating a Path Forward

Since 2016, there has been a substantial increase in the development of guidance for the generation, reporting, and use of real-world data/evidence (RWD/E) in healthcare decision-making. Several organizations (e.g., IDERHA, Duke Margolis, etc) have undertaken efforts to compile and compare guidances. However, analyzes of guidance are often quickly rendered outdated due to the continual publication of new documents—and gaps in guidance persist despite proliferation on certain topics like transparency and data quality. This session will identify areas of guidance redundancy and debate whether there is a need for additional guidance or if the current landscape is saturated.The session will begin with a brief overview (5 minutes) from the moderator, C. Daniel Mullins of current real-world data and real-world evidence (RWD/E) guidance issued by global stakeholders, presented by the moderator. This will be followed by a structured debate on the necessity of additional RWE guidance. Ashley Jaksa will present the position that further guidance is not required, advocating instead for the harmonization of existing guidance (15 minutes). In contrast, Sandipan Bhattacharjee will argue that the development of additional guidance is essential to support manufacturers in meeting the evolving evidence-generation requirements of regulatory and health technology assessment (HTA) bodies (15 minutes). Laura Pizzi will offer a critical commentary on both perspectives using an ISPOR lens, and engage the audience through a live poll to capture their views on the topic (15 minutes). Dr. Mullins will moderate a Q&A session with the audience (10 minutes).