PURPOSE: Regulators and Health Technology Assessment bodies are developing guidance to improve the quality of RWE studies for decision-making. NICE recently released its RWE Framework, which is a meaningful step toward comprehensive RWE guidance for comparative effectiveness studies. However, operationalizing NICE’s guidance can be challenging for researchers. This workshop will present a process for designing and implementing decision-grade comparative effectiveness studies, using best practices that meet NICE’s RWE Framework and practical experience from a use case.

DESCRIPTION: Stephen Duffield will provide an overview of NICE’s RWE Framework for comparative effectiveness studies (15 mins). Ashley Jaksa will then examine the utility of existing processes, templates, and tools referenced in NICE’s RWE Framework and outline a process that operationalizes RWE best practices across the lifecycle of a comparative effectiveness RWE study from design to reporting. Example processes and tools that will be discussed include a target trial approach, SPIFD, StartRWE, and NICE’s DataSAT tool. Where applicable, she will use examples from NICE’s Atrial Fibrillation RWE comparative effectiveness demonstration project as a case study (20 min). Solange Corriol-Rohou will provide her perspective on the process and tools discussed and identify where further guidance from NICE and best practices are needed. The workshop will conclude with an interactive question and answer session to promote engagement and clarify concepts (15 min). Researchers attempting to interpret and operationalize decision-maker guidance and decision-makers setting guidance on RWE’s use would benefit from attending this workshop. The speakers will solicit public comments and immediate feedback by conducting real-time polling of key learnings. The audience is expected to participate and provide their perspective and experience regarding RWE best practices.