Greg Daniel, PhD

Eli Lilly. former Deputy Director @DukeMargolis, former Brookings fellow. Editor-In-Chief, TIRS. Health policy. Opinions my own.

[MDIC @MDIConline]

TOMORROW: Our @MDICAnnualForum continues with a discussion on access and reimbursement including an update on our HEPV initiative! Learn more and register: https://t.co/3Lv95caHOT #MDICAPF2020 @Medtronic, @EdwardsLifesci, @CMSGov, @NHCouncil, @BCBSAssociation

[Greg Daniel, PhD @gregwdaniel]

@Nom_Nom_Now @DeSchmalbergDVM We have a new pup and received 1st shipment. But the nutrition content is for adults, not recomended puppy % protein, etc. Puppies need specific formulations, but cust service says same exact formulation is for all life stages and to just give more?

[Duke-Margolis @DukeMargolis]

In this month's @Health_Affairs, @DukeMargolis scholars and researchers develop models to pay for value for high cost medical technologies

https://t.co/B9INSfKvDB

[Greg Daniel, PhD @gregwdaniel]

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

[Duke-Margolis @DukeMargolis]

@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.

[Duke-Margolis @DukeMargolis]

#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

[Duke-Margolis @DukeMargolis]

Challenge of #COVIDTherapeutics early access provisions is that this removes individuals from trials. Including early access into a registry still allows for #RealWorldEvidence generation

[Ohio State Football @OhioStateFB]

Introduce yourself

#GoBucks #ToughLove

[Ohio State Football @OhioStateFB]

Stand Up, Stand Out

#GoBucks #ToughLove

[Lisa Simpson @DrSimpsonHSR]

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

[Duke-Margolis @DukeMargolis]

Read the most recent white paper https://t.co/Af4QVr9FJ9 to learn about how @FDA can better ensure drug safety through improved approaches to risk communication. @gregwdaniel @sarah_m_sheehan @DusetzinaS @CBGood23 @lillypad @jsross119

[Duke-Margolis @DukeMargolis]

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

[Greg Daniel, PhD @gregwdaniel]

Very important topic. Many opportunities for #RandomisedRWE to leverage vast and high quality #RWD for labeling supplements #RWEregulatory

[Duke-Margolis @DukeMargolis]

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

[Greg Daniel, PhD @gregwdaniel]

Ha! He’s great. Such and important topic we’re thrilled to host this important topic #RealWorldEvidence #RWEregulatory

[Jeannie Baumann @jeanniereporter]

"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)

[Greg Daniel, PhD @gregwdaniel]

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.

[Bray Patrick-Lake @BrayPatrickLake]

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

[Greg Daniel, PhD @gregwdaniel]

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

[Duke-Margolis @DukeMargolis]

Important question: To what extent do real-world outcomes need to mirror or match those that have been traditionally accepted in clinical trials? #RWEregulatory

[Greg Daniel, PhD @gregwdaniel]

Blinding might not be necessary if using more objective endpoint, clinical equipoise, larger tx effect, AND for modifying/supplementing the indication #RealWorldEvidence #RWERegulatory

[Duke-Margolis @DukeMargolis]

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

[Duke-Margolis @DukeMargolis]

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

[Duke-Margolis @DukeMargolis]

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 https://t.co/Iagpq4tYrM

[Greg Daniel, PhD @gregwdaniel]

We really need to learn from replication studies like this. Helps identify when observational #RealWorldEvidence #RWE is fit-for-use. @dukemargolis @OptumLabs https://t.co/eGvU4FVwGF…

[Duke-Margolis @DukeMargolis]

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.