ISSUE: Increasingly, real-world evidence (RWE) is used to make clinical assertions and influence the standard of care through regulatory, reimbursement, and clinical decision-making. High validity RWE is increasingly desirable and required. But, the industry has not yet reached consensus on what it means to produce “research-grade” evidence using “fit-for-purpose” data. As physicians, insurance, and regulators increasingly scrutinize RWE for quality, it is now an industry imperative to understand issues of data quality and design a strategy to produce high-validity evidence.

OVERVIEW: This panel will seek to unpack this complex issue. Dan Riskin, the panel moderator, will set the stage for discussion by highlighting key questions, including: What are the differences between traditional and advanced RWE? What factors influence credibility of RWE? Where are there still gaps in data accuracy and population generalizability? Tina Boussard will describe scientific efforts to use advanced data sources and how this influences data quality. Keri Monda will address how the pharmaceutical industry is innovating in advanced RWE while maintaining and even growing efforts in traditional RWE. Nancy Dreyer will comment on advances in evidence validity and outline current thinking on research-grade RWE in the era of the 21st Century Cures Act. The moderator will ensure that at least 15 minutes of the session is devoted to soliciting audience interaction and feedback on the competing viewpoints.