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The European Medicines Agency (EMA) and some national medicines agencies have been investing in access to RWD. Building on this experience, in 2021, the European Medicines Regulatory Network (EMRN) initiated plans to create an EU-wide distributed network of RWD named the Data Analytics and Real World Interrogation Network (DARWIN EU). Similarly, the US FDA has their Real Word Evidence Program which includes documentation for the RWE Program RWE Program Framework, published in 2018. Ideally, such multinational RWD initiatives should be guided by FAIR principles, rather than creating clinical data silos which are all too often lost to secondary reuse.
Other registries and efforts
We just want to briefly mention and link out to other relevant data registries and efforts, without going into further details or FAIR assessments:
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