ISSUE: There are many studies and reviews focused on the ability of real world evidence studies to replicate and reproduce randomized clinical trials. However, we often use RWE to answer questions that an RCT is not designed to answer. Can RWE replicate RCTs and if they do does that really give us comfort that RWE is credible and reliable?

OVERVIEW: RCT replications studies using secondary data sources are currently producing much awaited data to see how well RWE can produce ‘accurate’ results as defined by replicating RCT findings. DUPLICATE is sponsored by the FDA and intends to replicate 30 completed Phase III or IV trials and to predict the results of seven ongoing Phase IV trials using Medicare and commercial claims data. OPERAND conducted by Brown University and Harvard Pilgrim Health Care Institute (funded by unrestricted grants from a consortia of pharmaceutical companies) intends to replicate the ROCKET-AF trial for atrial fibrillation and the LEAD-2 trial for Type 2 diabetes control using claims from commercial and Medicare Advantage plans and electronic medical record data from OptumLabs Data Warehouse. This panel will explore viewpoints from both RWE experts involved in these duplication studies and as RWE experts, and from the experts who understand the strength of evidence that is needed in order to make causal inference or comparative effectiveness/efficacy claims. The moderator will open the session with a 5 minute introduction to the issue and each speaker will have 10 minutes to discuss their view point. There will be interactive use of polling through the zoom platform and at least 20 minutes for audience Q&A or for the panelists to query each other on their viewpoints if on-demand. This session will be of interest to HEOR professionals in life sciences industry, academia, regulatory or payer space who are interested in RWE.