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9 Sep, 5 tweets, 7 min read
Today's a very big day fo #AI medical research
There are major publications of consensus statements and guidelines published @NatureMedicine @LancetDigitalH @bmj_latest on protocols, trial design, and reporting
Here's my commentary @NatureMedicine nature.com/articles/s4159…
Here are the Consensus Statements which reflect extraordinary, international, collaborative effort
Led by @DrXiaoLiu @Denniston_Ophth and colleagues
nature.com/articles/s4159…
nature.com/articles/s4159…
@NatureMedicine 👏👏👏🙏🙏
These are the guideline publications @LancetDigitalH
thelancet.com/journals/landi…
thelancet.com/journals/landi…
At the @bmj_latest
bmj.com/content/bmj/37…
bmj.com/content/bmj/37…
And at @LancetGastroHep by the endoscopists who have been leading randomized #AI trials, by @tberzin and colleagues
thelancet.com/journals/langa…

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More from @EricTopol

Eric Topol Profile picture
9 Sep
My podcast w/ Paul Offit, one of the world's leading lights on vaccines, regarding #SARSCoV2 vaccine development
medscape.com/viewarticle/93… @Medscape
It's rich and I'll summarize key points here 🧵
1. "It's an unprecedented moment...as long as the Phase 3 trials don't get truncated"
2. Things we're learning about the virus
--not affected by seasons
--can cause a vasculitis
--unusual multi-system inflammatory syndrome in children
--strong predilection for nursing homes
3. What about #LongCovid?
Read 14 tweets
Eric Topol Profile picture
4 Sep
These vaccine announcements tell us how it's virtually impossible to have Phase 3 complete by November 3rd
23,000 of 30,000 currently enrolled @Pfizer/@BioNTech_Group program

1/
That means another 24,000 participants need to get their 2nd dose still, which occurs a month after the 1st.
Then 2-3 weeks to get the full immune response.
Then exposure to infections
Then moderate or severe infections as events
2/
Pfizer CEO: "We expect by end of October, we should have enough...to say whether the product works or not."
The 1st interim analysis is at 32 events
statnews.com/2020/09/02/exp… @matthewherper @statnews
Even 32 events for placebo, 0 vaccine (likelihood ~0) wouldn't cut it to stop 3/
Read 6 tweets
Eric Topol Profile picture
3 Sep
Today we learned ~1/3 Big Ten athletes who were #COVID19 + had abnormal heart MRIs, consistent w/ myocarditis, even those without symptoms. If anyone still is questioning whether this virus attacks the heart, it's denialism.
There have been multiple reports of heart involvement with #COVID19, including young athletes, and replication of @GladstoneInst iPSC-> heart cell findings. Very little is known about heart inflammation among asymptomatics (unlike lung Δs)
Documented #SARSCoV2 particles in heart cells in a tragic case of an 11-year-old girl
Read 6 tweets
Eric Topol Profile picture
3 Sep
A little primer on independent Data and Safety Monitoring Boards (DSMB), who will be reviewing the #SARSCoV2 vaccine trials to adjudicate safety and efficacy, making recommendations to the clinical trialists 1/
Consists of a multidisciplinary group of several members: clinical trialists, biostatistician, bioethicist, and experts in topic (virologist, immunologist, epidemiologists, vaccinologists)
The timing/schedule of data review usually based on enrollment 2/
The data are teed up by the biostatisticians. The DSMB is blinded to vaccine or placebo groups. There is ordinarily a time lag/gap from the "cleaned" dataset reviewed by DSMB that is behind ongoing events 3/
Read 8 tweets
Eric Topol Profile picture
2 Sep
On the #SARSCoV2 immune response and vaccine I just did a podcast with Dennis Burton, a leading immunologist and vaccinologist and co-faculty @scrippsresearch. We covered so much a long🧵summary was needed
soundcloud.com/prescrippsions… 1/x
Optimism. "The pandemic is not going to be with us forever"
(This comes from a leader of the HIV vaccine program) 2/x
1st line of defense, interferons: will they likely be helpful given as an early intervention?
Yes, but we have to be very careful 3/x
Read 16 tweets
Eric Topol Profile picture
1 Sep
Very good news on durable IgG antibodies to #SARSCoV2 from the Iceland experience
Just published @NEJM
nejm.org/doi/full/10.10… >4 months out
Iceland was one of the best performing countries vs #COVID19, starting PCR screening in January, before there was even a patient diagnosed. As a result, along with tracing/isolation, they have a seroprevalence of only 0.9% (US is now >14%, estimated) and IFR 0.3%.
The editorial is rich with context
nejm.org/doi/full/10.10…
1. "Unprecedented snapshot of seroconversion rates" with various antibody isotopes, different antigens
2. 56% cases confirmed by virus (PCR) testing so 44% infections would've been missed w/o antibody
3. 2 Waves graphic
Read 4 tweets

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