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Whether you're a heart expert or anyone else, this is worth digesting.https://twitter.com/StanfordDeptMed/status/1224821684139589633 …
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This use of technology & data science provides a basis for rational policy intervention and measurement of effect. Nice work!
@DukeForgehttps://twitter.com/MaryniaKolak/status/1223797487569461248 …
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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@FDACommissionerPrikaži ovu nitHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
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.
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This is understandable because 21st Century Cures had an error in the definition that was corrected in the User Fee legislation.
@VPrasadMDMPHPrikaži ovu nitHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
See FDA reference: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence … .
@ZacharyBrennanPrikaži ovu nitHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
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/2IYicBMPrikaži ovu nitHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The eye as the gateway to human biology and pathophysiology!https://twitter.com/dtfeinberg/status/1222909355475054592 …
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Another depiction of the reason that new policies are needed.
@DukeForgehttps://twitter.com/MaryniaKolak/status/1222554475690364930 …
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Right person for the job.
@DukeForgehttps://twitter.com/DukeForge/status/1222628729731604488 …
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These are persistent and diligent researchers. Congrats!https://twitter.com/DrDave01/status/1222314865731104768 …
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Great to see transition to strong leadership and continued key role for predecessor! Go Josh and Eric and team.https://twitter.com/jdnashville/status/1221951094550560770 …
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Also feel compelled to point out that FDA has limited people to do enforcement and many more egregious issues are not fully addressed because there are only a limited # of lawyers & if they are tied up on this other critical issues will go unaddressed.
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I think its time for FDA to fine a few offenders to wake up the academic community. A couple of fines would probably do the job.
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If all people enrolled in SCTs enrolled in quality trials, we'd be a lot more knowledgeable about appropriate treatment. Frustrating to see the lack of attention to the ethical issue of doing a human experiment with no chance of creating meaningful knowledge.
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Dr. Woodcock at FDA coined the term SCT (small, crappy trials) to characterize many of the trials done in academic centers--too small to answer meaningful questions, many with poor designs & no analysis plan. These SCTs often aren't finished & aren't published.
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Some elements of this article are a bit off (for example, all clinical trials are not meant to inform practice, as in Phase I & mechanistic trials), but the basic findings are consistent across multiple studies.
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Profound difference remains between industry (good job reporting results) and academia/govt (not a good job). Compliance with legal requirement to report clinical trial results on http://ClinicalTrials.gov : a cohort studyhttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33220-9/fulltext#.XizIpAzdw3s.twitter …
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Another classic! Forge Wednesday Roundup - January 22, 2020 https://forge.duke.edu/blog/forge-wednesday-roundup-january-22-2020 …
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