What is Real World Evidence
Challenges of RWE
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Methodological limitations: methods of data recollection, multiple
potential bias in patient selection
•
Quality of data not standarized
•
Implications of results far from clear, particularly from a regulatory
perspective (need i.e. EMA, FDA guidelines)
•
Will be very costly to develop them further
•
Ongoing initiatives (FDA, NIH) to implement RWD from electronic
medical records
