Saturday, February 01, 2020 6:10:57 PM
Of course they are told about possible side effects. That is part of informed consent.
Consider this, the patients will have been informed of the possible side effects. They will also have been informed of the possible benefits of 2-73. That information will allow each subject to come to his/her own conclusion about whether they are getting the drug or a placebo.
That doesn't mean the conclusion they come to will be correct.
It is clear that the long term trend for an AD patient is down. However the shorter term trend can be variable. That is the reason the MMSE is not considered reliable over the short term according to the FDA. FDA says it takes 3 years of data before the MMSE is considered reliable.
That means that any patient could be having good days and think that they are getting the drug when they are not.
McF might have well not said what he did and avoided any controversy. I don't think he created a serious issue for the trial.
Consider this, the patients will have been informed of the possible side effects. They will also have been informed of the possible benefits of 2-73. That information will allow each subject to come to his/her own conclusion about whether they are getting the drug or a placebo.
That doesn't mean the conclusion they come to will be correct.
It is clear that the long term trend for an AD patient is down. However the shorter term trend can be variable. That is the reason the MMSE is not considered reliable over the short term according to the FDA. FDA says it takes 3 years of data before the MMSE is considered reliable.
That means that any patient could be having good days and think that they are getting the drug when they are not.
McF might have well not said what he did and avoided any controversy. I don't think he created a serious issue for the trial.
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