I would take a deep breath and wait for AZ to release primary efficacy results to see if there is any meaningful difference from the prespecified interim analysis reported yesterday. Usually there will be some differences. It happened with the other vaccines also.
It is quite extraordinary for a DSMB to express concern over release. Not sure if there was a misunderstanding when the DSMB asked AZ to release results, if it specifically told them to wait and release Primary Analysis or not.
Again unless the difference is meaningful not sure what to make of this other than it's pretty strange. Never happened to me in any of the trials that I have been involved with.
Generally in trials that Ive been involved with, DSMBs review data & recommend release when they see endpoints are met. They don't often specify exactly what to release. There's discretion to study team. Maybe they expected AZ to release primary analysis but AZ released interim?
I remember when the Moderna vaccine FDA briefing document came outc @DrEricDing sent a tweet showing that their data did change from the interim analysis that was released earlier and the final analysis reported in guidance document. Not able to locate the tweet.
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I called it a blunder then.
Why because it didn't make sense as the right judgment call.
We were essentially saying no to a vaccine when we we had 200,000 new daily cases a day and 3000 new deaths a day.
Too many pundits criticized the initial Astra Zeneca trials. Overstating procedural problems double blind placebo controlled trials. Most of these pundits were purists who had never led a randomized trial themselves. Let alone in lightning speed.
5/ The rate of DIC and cerebral venous thrombosis appear higher than expected baseline.
6/ Since these adverse events are very rare, the risks of COVID high, & the high efficacy of the vaccine, the @EMA_News recommended that the benefits of the vaccine outweighed the risks.
In May 2020, we would have been happy with any vaccine by 2022
By fall 2020, we were going to be happy if any vaccine was 50% effective.
By Feb 2021, we have vaccines with 95% efficacy but we worry about why it's not 100% effective, & if it prevents transmission or long COVID.
What we can control: Try and vaccinate as many people as possible, globally, so that there are less immunologically unprepared hosts for the virus to multiply in.
What we cannot control: The innate ability of the virus to mutate.
What we can do: Take precautions till a significant proportion of the population you live in has been vaccinated.
What we can't do: Create new vaccines in a month. It's going to take time for boosters that improve on the protection offered by current vaccines to arrive.
1/ Change in diagnostic criteria. MDE not CRAB. @TheLancetOncol
2/ Treatment of high risk SMM. Early preventive therapy with Len or Len/dex significantly delays end organ damage in high risk SMM. @SagarLonialMD@mvmateos
3/ Role of Transplant.
Early versus Delayed Transplant. Similar overall survival at 8 years means selected patients with standard risk myeloma can opt to delay transplant if feasible.