Greg Daniel, PhD

@emilycob of @DukeMaroglis @duke_pophealth COVID 19 is an ideal use case for #RealWorldData We need to generate high quality evidence, very quickly. Good data allows for the best use of scarce resources. @PCORnetwork can pull in populations that tend to be underenrolled.

Thank you again to our speakers and everyone who joined the #RWEregualtory workshop and contributed to a robust discussion on the use of RWD collected during randomized studies embedded in clinical care settings to generate RWE @gregwdaniel

"I won't be here tomorrow, but Mark McClellan will be here, so that'll be good too," @dukemargolis's Gregory Daniel says to laughter at the #RWEregulatory event (McClellan of course ran both CMS and FDA at one point)

Hmm. Traditional data structures @dukemargolis #RWEregulatory w/ #mHealth apps & wearables noticeably absent. We need new structures, designs & novel endpoints to capture true #patient QOL, function & experience that are revealed by apps & wearables. #DigitalBiomarkers @evidation

Important question: To what extent do real-world outcomes need to mirror or match those that have been traditionally accepted in clinical trials? #RWEregulatory

We are back with Simon Skibsted @novonordisk, Rita Redberg @RFRedberg, Satrajit Roychoudhury @pfizer, Nancy Dreyer @IQVIA_global, Peter Stein @US_FDA to discuss the role and use of blinding in randomized trials to minimize bias #RWEregulatory