Achieving more pragmatic approaches to clinical evidence generation requires an understanding of potential approaches and regulatory acceptance of such approaches. This webinar, which included speakers from Exact Sciences, Johns Hopkins University, and Flatiron Health reviewed recent FDA draft guidance regarding the use of RWD/RWE in medical device studies that outline approaches and considerations for more pragmatic research. Experts also delved into case studies of companies leveraging RWE, highlighting how each case accounts for regulatory guidance and acceptance.
