I know you are making an argumentum ad absurdum, but many hold exactly this position.
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Replying to @matthewherper @VPrasadMDMPH
We need the FDA primarily to assure drug safety and quality, including that medicine sold as X is exactly X. Efficacy as value is subjective, and also fluid in context of new and competing Rx. So what's questionable is if the FDA can--or should--judge efficacy.
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Replying to @ESchattner @VPrasadMDMPH
The FDA should judge efficacy, and without that I don’t know what trials we get.
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Replying to @matthewherper @VPrasadMDMPH
We'd still get phase 1 and 2. Then maybe go straight to RWE for 3-4? (this is a question, I am not sure)
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What is being debated is if RWE of approved treatments can be used as a historical control in phase 3 studies - to see if you can do away with RCTs (I'm skeptical) PS Blood letting became standard practice based on RWE. Many doctors swore it helped their patients.
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The answer is, usually if not nearly always, no. The sole exception is for really large effect sizes.
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