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14 June 2023

Josie Wolfram, Eleanor Ralphs, Alexander Schacht

In the last decade, pharmaceutical companies have increasingly undertaken acquisition and use of RWD for evidence generation.  This is an area where a lot of functional expertise is needed (data management, epidemiology, patient reported outcomes, clinical practice), but still statisticians have an important role to play.  This interactive session will explore the role of the statistician in evidence generation based on RWD.

This session will cover 3 parts.  First, we will provide some tools and insights for how to ensure that teams have a good understanding of the strengths and limitations of RWD / RWE.  This begins with a solid understanding of the data generation mechanism and how it is similar and different from an RCT and the implications for interpretation of results.  Second, a case study will be examined in detail to show the difference between good / bad (clear / unclear) communication of RWD results.   Finally, we will discuss how statisticians can influence good communication and credible interpretation.  For example, do not just deliver tables, highlight the unusual, encourage discussion beyond the surface, and [significantly] think/talk about p-values judiciously in the context of RWD. 

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