Tuesday, July 16, 2024 11:45:11 AM
If individual patient-level data was an absolute FDA requirement for ECA then no lethal cancer drug trial could ever be conducted again.
- In that case, the placebo arm must parish to be able to compare that data to the treatment arm. No placebo patient could ever be randomized to treatment which would be very unethical and the FDA knows that, just the shorts are still that dumb to not realize this.
Also in the treatment arm every patient must be 100% identical (twin brothers and sisters?) to the placebo arm patient otherwise the individual patient-level data argument is mute.
- In case no individual patient-level data is available for a certain lethal cancer treatment trial, no ECA comparison can ever be made.
Therefore short's claim that the FDA will always demand individual patient-level data for ECA comparison is idiotic dumb and stupid
- In that case, the placebo arm must parish to be able to compare that data to the treatment arm. No placebo patient could ever be randomized to treatment which would be very unethical and the FDA knows that, just the shorts are still that dumb to not realize this.
Also in the treatment arm every patient must be 100% identical (twin brothers and sisters?) to the placebo arm patient otherwise the individual patient-level data argument is mute.
- In case no individual patient-level data is available for a certain lethal cancer treatment trial, no ECA comparison can ever be made.
Therefore short's claim that the FDA will always demand individual patient-level data for ECA comparison is idiotic dumb and stupid
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