Brilliant blog, Saloni! Have you looked into the development of COVID-19 vaccines in countries outside the Global North (Vietnam, China, Russia, etc.) and what role governments played in supporting these, equivalent to Operation Warp Speed? Given the experience of vaccine nationalism during the pandemic (including how it undermined COVAX) such efforts played an important part in saving lives, and in future pandemics could prove central to achieving herd immunity globally.
Really enjoyed this, the parallel-phase and rolling-review points are the ones people usually miss.
There's a lesser-known regulatory lever from the same era I'd love to compare notes on sometime: the public health surveillance exception (45 CFR 46.102(l)(2)), which let some observational cohort studies skip standard informed consent entirely during COVID. I managed a site for one of the big NIH-funded cohorts that used it, and it's a fascinating case study in the same "how did things move fast" question, with a more complicated answer.
The useful line here is between speed and shortcuts. Most of the Covid trial speed came from cutting idle time, not evidentiary corners: phases overlapped, data got reviewed as it arrived, financial risk was carried up front instead of stage by stage.
What makes that uncomfortable is that medicine usually treats delay as the cautious default. But waiting isn't the same as rigor. Sometimes it's just a sequence nobody has been forced to redesign.
The pandemic made the cost of that waiting visible for once. The part that should bother us is that some of it was never specific to Covid. It was the first time the system had a reason to count the calendar as a cost, and it turned out it always was one.
Brilliant blog, Saloni! Have you looked into the development of COVID-19 vaccines in countries outside the Global North (Vietnam, China, Russia, etc.) and what role governments played in supporting these, equivalent to Operation Warp Speed? Given the experience of vaccine nationalism during the pandemic (including how it undermined COVAX) such efforts played an important part in saving lives, and in future pandemics could prove central to achieving herd immunity globally.
I haven't yet! I'm less familiar with that, but would be interested to read more on the topic.
Really enjoyed this, the parallel-phase and rolling-review points are the ones people usually miss.
There's a lesser-known regulatory lever from the same era I'd love to compare notes on sometime: the public health surveillance exception (45 CFR 46.102(l)(2)), which let some observational cohort studies skip standard informed consent entirely during COVID. I managed a site for one of the big NIH-funded cohorts that used it, and it's a fascinating case study in the same "how did things move fast" question, with a more complicated answer.
Happy to share details if useful.
The useful line here is between speed and shortcuts. Most of the Covid trial speed came from cutting idle time, not evidentiary corners: phases overlapped, data got reviewed as it arrived, financial risk was carried up front instead of stage by stage.
What makes that uncomfortable is that medicine usually treats delay as the cautious default. But waiting isn't the same as rigor. Sometimes it's just a sequence nobody has been forced to redesign.
The pandemic made the cost of that waiting visible for once. The part that should bother us is that some of it was never specific to Covid. It was the first time the system had a reason to count the calendar as a cost, and it turned out it always was one.