Greg Daniel, PhD
@gregwdaniel
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Eli Lilly. former Deputy Director @DukeMargolis, former Brookings fellow. Editor-In-Chief, TIRS. Health policy. Opinions my own.
Washington, DC
Joined August 2012
RT @MDIConline: TOMORROW: Our @MDICAnnualForum continues with a discussion on access and reimbursement including an update on our HEPV init….
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RT @DukeMargolis: In this month's @Health_Affairs, @DukeMargolis scholars and researchers develop models to pay for value for high cost med….
healthaffairs.org
Innovative medical products offer significant and potentially transformative impacts on health, but they create concerns about rising spending and whether this rise is translating into higher value....
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Yet another example of how #RWE helps us learn about impact of treatment (this time, possible COVID-19 treatments) as fast as possible, broader populations.
@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.
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RT @DukeMargolis: #COVIDTherapeutics webinar is live . We need to identify likely target molecules, streamline testing and approval, scale….
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RT @DukeMargolis: Challenge of #COVIDTherapeutics early access provisions is that this removes individuals from trials. Including early ac….
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RT @DrSimpsonHSR: Another great discussion table. Glad to reconnect w Greg Daniel now at @EdwardsLifesci n meet Megan Coder from @DTXAllian….
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RT @dukemargolis: Read the most recent white paper to learn about how @FDA can better ensure drug safety through im….
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RT @dukemargolis: Dr. Jacqueline Corrigan-Curay @US_FDA provides the opening remarks at the Improving the Implementation of Risk-Based Moni….
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Very important topic. Many opportunities for #RandomisedRWE to leverage vast and high quality #RWD for labeling supplements #RWEregulatory.
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.
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Ha! He’s great. Such and important topic we’re thrilled to host this important topic #RealWorldEvidence #RWEregulatory.
"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).
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Totally agree Bray! These techs are the future (and present) for actually efficiently measuring what matters to patients. Should be critical for regulatory and payer decisions.
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
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They don’t. Should be trying to measure the most meaningful outcomes from patient perspective. Hopefully those are important for regulators and payers too and can be measured #RealWorldEvidence #RWEregulatory.
Important question: To what extent do real-world outcomes need to mirror or match those that have been traditionally accepted in clinical trials? #RWEregulatory.
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Blinding might not be necessary if using more objective endpoint, clinical equipoise, larger tx effect, AND for modifying/supplementing the indication #RealWorldEvidence #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.
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RT @dukemargolis: Thank you to all of our speakers and to all of you who attended the workshop physically and via webcast! We will be conti….
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RT @dukemargolis: 1/4 Out today from @dukemargolis/@LeavittPartners in @Health_Affairs: study of factors influencing #AccountableCareOrgani….
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We really need to learn from replication studies like this. Helps identify when observational #RealWorldEvidence #RWE is fit-for-use. @dukemargolis @OptumLabs .
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RT @dukemargolis: We need new drugs and vaccines for diseases faced by people in tropical climates, including soldiers. At the Walter Reed….
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