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