I’ve noted discussion and some with concern about the possibility of the FDA raising concerns about the potential of a side effect diarrhoea unblinding the trial.
If that we’re to be an issue, then how could you possibly re visit a drug that has a side effect compared to the placebo. You would never be able to test the drug.
you can’t give another medication as it would unblind it before starting.
I can only assume you need to interpret the data as it is.
Q. How can you keep a trial blinded that has a known side effect?
The best time is before it’s a known side effect and that’s
with the first trial which we’ve already done.
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