The GetReal project aimed to show how robust new methods of real-world evidence (RWE) collection and synthesis could be adopted earlier in pharmaceutical research and development (R&D) and the healthcare decision-making process. To attain this goal, case studies were drawn from the portfolios of EFPIA partner organisations to explore new analytical methods (WP4, WP2, WP1) or study designs (WP2, WP3), or to explore stakeholder views of these methods or study designs (WP1), in specific disease areas.
Some case studies were more historic in nature – to test analytical methods on medicines that have already passed through regulatory and health technology assessment (HTA) that might have been useful earlier on in the process or stakeholder views of these methods (WP1, WP2, WP4). Other case studies included medicines in development that were thought to have a particularly large efficacy-effectiveness gap (see Clarifying the Issues for a definition) or a difference in expectations between regulators and payers (WP2, WP3).
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