Real-World Evidence

Despite investment in RWE, many life sciences leaders question how and when RWE influences medical value assessments. Consequently, we find a bifurcation across the industry around how much effort and investment in RWE is warranted. For some organizations, the 21st Century Cures Act signaled that investment in RWE would yield positive ROI—if FDA accepts RWE, non-regulatory decision-makers would follow suit. But other manufacturers are in a wait-and-see period; waiting for clear guidelines and consistent customer commitment to accepting RWE studies. With so much uncertainty about how payers, providers, clinical societies, and HTAs use RWE, we have yet to reach a tipping point on RWE acceptance.

In August 2020, Advisory Board hosted a live workshop for medical leaders to discuss the capabilities of a best-in-class RWE organization, and to hear how their peers are advocating in investment for RWE and developing their organizations.