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Real-world evidence: the devil is in the detail – published online 15/07/2020

Mugdha Gokhale, Til Stürmer, John B. Buse

The healthcare community is abuzz with discussions about real world evidence (RWE), which provides evidence regarding the utilisation and potential benefits and harms of healthcare interventions, based on data from routine clinical practice. While the reflection of diverse real-world patterns increases the attractiveness of RWE, it also increases the chance of several biases in real-world studies. In this issue (https://doi.org/10.1007/s00125-020-05217-1), Gokhale et al summarise key elements in RWE studies, including commonly encountered issues and methods to address these. While there is no one-size-fits-all solution to designing RWE studies, the authors explain that critical elements include a clear prespecified protocol with a well-defined research question, a fit-for-purpose data source, therapeutically equivalent treatments as comparators, robust state-of-the-art study design, analytical techniques to minimise biases, and clearly reported methods and results per published guidelines. The review also points to some newer areas of application of RWE that are relevant to diabetes research and beyond. The figures from this review are available as a downloadable slideset.

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