Eli Lilly. former Deputy Director @DukeMargolis, former Brookings fellow. Editor-In-Chief, TIRS. Health policy. Opinions my own.
Washington, DC
Joined August 2012
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Greg Daniel, PhD retweeted
TOMORROW: Our @MDICAnnualForum continues with a discussion on access and reimbursement including an update on our HEPV initiative! Learn more and register: bit.ly/2KLay3w #MDICAPF2020 @Medtronic, @EdwardsLifesci, @CMSGov, @NHCouncil, @BCBSAssociation
Greg Daniel, PhD retweeted
In this month's @Health_Affairs, @DukeMargolis scholars and researchers develop models to pay for value for high cost medical technologies
healthaffairs.org/doi/full/1…
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.
Greg Daniel, PhD retweeted
#COVIDTherapeutics webinar is live
We need to identify likely target molecules, streamline testing and approval, scale up manufacturing capacity and improve #RealWorldEvidence for treatments that come to market via accelerated and emergency approval pathways
Greg Daniel, PhD retweeted
Challenge of #COVIDTherapeutics early access provisions is that this removes individuals from trials. Including early access into a registry still allows for #RealWorldEvidence generation
Greg Daniel, PhD retweeted
Another great discussion table. Glad to reconnect w Greg Daniel now at @EdwardsLifesci n meet Megan Coder from @DTXAlliance
Need guidance on #ptpreferences mst, transparency on models used in #ValueAssessment #PuttingPatientsFirst @NHCouncil
Greg Daniel, PhD retweeted
Read the most recent white paper bit.ly/2YlL9pS to learn about how @FDA can better ensure drug safety through improved approaches to risk communication. @gregwdaniel @sarah_m_sheehan @DusetzinaS @CBGood23 @lillypad @jsross119
Greg Daniel, PhD retweeted
Dr. Jacqueline Corrigan-Curay @US_FDA provides the opening remarks at the Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations public workshop
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
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)
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
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
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
Greg Daniel, PhD retweeted
Thank you to all of our speakers and to all of you who attended the workshop physically and via webcast! We will be continuing the discussion tomorrow at 9am with key takeaways from today. #RWEregulatory
Greg Daniel, PhD retweeted
1/4 Out today from @dukemargolis/@LeavittPartners in @Health_Affairs: study of factors influencing #AccountableCareOrganization (ACO) survival in #Medicare's flagship alternative to fee-for-service, #MSSP. @WillBleser @DavidMuhlestein #HealthPolicy bit.ly/2Jl0gYG
We really need to learn from replication studies like this. Helps identify when observational #RealWorldEvidence #RWE is fit-for-use. @dukemargolis @OptumLabs optumlabs.com/news-events/ne…
Greg Daniel, PhD retweeted
We need new drugs and vaccines for diseases faced by people in tropical climates, including soldiers. At the Walter Reed Army Institute of Research (@WRAIR), Monika Schneider and @dave_ridley of @dukemargolis discussed incentives for companies developing drugs and vaccines.
Greg Daniel, PhD retweeted
Martin Burruano of @IH_news and Bernie Good of @UPMCHealthPlan discussing Rx outcomes-based contracting at #ACHPSpring19.
