A Framework for Regulatory Use of Real-World Evidence
https://healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_white_paper_2017.09.06.pdf
Potential Benefits of RWD/RWE in Regulatory Decision-Making
· Enables evidence development in settings where traditional RCTs are impractical to conduct (e.g. rare diseases, etc.);
· Fills important evidentiary gaps that are not typically addressed with traditional RCTs (e.g. real-world uses of products in patients with multiple comorbidities, long-term outcomes, etc.);
· May allow sponsors to generate evidence in support of an efficacy claim that is potentially more useful to payers and patients;
· May significantly reduce time and cost of evidence development for some regulatory decisions.