Robert M Califf

@califf001

cardiologist, trialist, outcomes researcher, former FDA Commissioner

Duke Univerrsity
Vrijeme pridruživanja: svibanj 2011.

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  1. prije 13 sati

    Whether you're a heart expert or anyone else, this is worth digesting.

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  2. 3. velj

    This use of technology & data science provides a basis for rational policy intervention and measurement of effect. Nice work!

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  3. 31. sij
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  4. 31. sij

    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.

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  5. 31. sij

    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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  6. 31. sij

    This is understandable because 21st Century Cures had an error in the definition that was corrected in the User Fee legislation.

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  7. 31. sij
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  8. 31. sij

    Critical error in this article:15% replicability referred to retrospective, observational tx comparisons. RWD/RWE includes randomization & other methods to enable causal inference. Stresses Importance of Data, RWE in First All-Hands Meeting

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  9. 30. sij

    The eye as the gateway to human biology and pathophysiology!

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  10. 30. sij

    Another depiction of the reason that new policies are needed.

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  11. 30. sij
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  12. 30. sij

    These are persistent and diligent researchers. Congrats!

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  13. 28. sij

    Great to see transition to strong leadership and continued key role for predecessor! Go Josh and Eric and team.

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  14. 25. sij

    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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  15. 25. sij

    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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  16. 25. sij

    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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  17. 25. sij

    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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  18. 25. sij

    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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  19. 25. sij

    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 : a cohort study

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  20. 25. sij

    Another classic! Forge Wednesday Roundup - January 22, 2020

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