ASA Connect

 View Only

White Paper: "A Framework for Regulatory Use of Real-World Evidence"

  • 1.  White Paper: "A Framework for Regulatory Use of Real-World Evidence"

    Posted 09-06-2017 21:05

    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.