• Ravi Jandhyala.
• Medialis Ltd, Wolverton Mill, Milton Keynes, England, UK.
• Curr Med Res Opin. 2023 Dec 1; 39 (12): 155115581551-1558.

ObjectiveLow rates of inclusion of real-world evidence (RWE) during regulation may arise from lack of clarity and consensus on its definition. A conceptually mature definition of RWE may have pragmatic utility, increasing its inclusion during regulation. The aim was to develop a definition of RWE to promote inclusion in regulatory submissions and assess its conceptual maturity.MethodsThirteen medical affairs pharmaceutical physicians completed two qualitative online surveys to generate items needed in a definition of RWE. Items that reached a consensus index of > 50% (CI > = 0.51) were retained in the final definition. The maturity of the definition was assessed using concept analysis.ResultsAfter attrition, 11 participants completed the study and generated 18 items to be included in a definition of RWE. All items reached the consensus threshold and were included. The definition was conceptually mature on three of the four dimensions: the potential for a consensual definition across stakeholders, a description of its characteristics and clear preconditions and outcomes. Further research is needed to delineate the boundaries of RWE.ConclusionsA definition of RWE was generated that may increase its inclusion during medicines regulation, especially with further refinement from regulators and other stakeholders.

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