The key to the value of RWD will be scientific consensus about how to rigorously analyze and draw conclusions from what are currently novel data sources. This consensus is developing steadily, driven in large part by scientific guidance from regulatory authorities.
Since 2021, a stream of guidance documents has outlined the US Food and Drug Administration thinking on crucial scientific issues such as the evaluation and documentation of data quality and the use of registries as means to organize RWD collection, in a way that can support regulatory decisions. Although regulators will need to continue building on existing scientific guidance, the leap in consensus around RWD use in the past few years is notable.
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