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Yeah, I agree you need a full up to standard clinical trial to really get something like this into the US medical system under normal circumstances. I was just
by zeku 6y ago
Yeah, I agree you need a full up to standard clinical trial to really get something like this into the US medical system under normal circumstances.
I was just mentioning that things can be learned from this study retrospectively by creating a control group from an EHR.
It has validity in the short term for MD's who might begin using this treatment under our fast track system we're using for COVID stuff.
If this trial was done at my institution and my team already had all of the paperwork out of the way with regards to the data access we could have something useful in a week or two out the door. So I hope this will be done by someone somewhere, just to save lives in short term.
- akiselev 6y agoMy apologies, I misunderstood your previous reply. I'm just afraid that loosening standards in this specific crisis is walking a really fine line. It makes sense during short burn epidemics like ebola where the fatality rate is so skewed, but exposing millions of people to HCQ during an extended highly infectious pandemic, especially without proper screening, is dangerous. Small price to pay if we're talking about something safe like aspirin or if HCQ cuts the CFR in half but if it's only a 10-20% difference, or the effect disappears with a larger sample size, or the mad rush for the drug causes a breakdown in quality control, or the demand deprives people who need it for other reasons - there's a very high chance of worsening quality of life for many people and creating a net negative. What is the fast track system for COVID? I've seen the emergency use authorizations for clinical testing but not any for new treatments other than the usual off label use.