Critical error in this article:15% replicability referred to retrospective, observational tx comparisons. RWD/RWE includes randomization & other methods to enable causal inference. @Hahn Stresses Importance of Data, RWE in First All-Hands Meetinghttps://scl.io/2IYicBM
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See FDA reference: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence … .
@ZacharyBrennan1 reply 2 proslijeđena tweeta 5 korisnika označava da im se sviđaPrikaži ovu nit -
This is understandable because 21st Century Cures had an error in the definition that was corrected in the User Fee legislation.
@VPrasadMDMPH1 reply 1 proslijeđeni tweet 3 korisnika označavaju da im se sviđaPrikaži ovu nit -
We worried at the time that the terms RWD & RWE would be hijacked to foster low quality research. This must be fought, because well done RWD & RWE with proper use of methods for causal inference is HIGHER quality & more generalizable.
1 reply 2 proslijeđena tweeta 9 korisnika označava da im se sviđaPrikaži ovu nit
We will all learn as we go with this. Hats off to Hahn, Abernethy, Woodcock, Shuren, Marks et al for continuing to work on this. @DrAbernethyFDA @FDACommissioner
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