The kicker is that when they send such a trial to the FDA, there's no warning that patients with heart problems should not take the drug. There are reasons why early trials, in particular, try to include healthy people -- in Phase I you don't want their pre-existing conditions to create false impression of safety risks. But if the phase 3 trials (if any....) excluded people with any condition that you have, it means that safety or net benefit in people like you has not been tested.
Another measure to look at is, of the patients who were screened and willing to participate, what percentage were found eligible to participate (whether they ultimately agreed to or not)? If 90% of screened people were eligible, great. If only 20% of screened people with the condition to be treated were eligible, that means it is a highly selected group and most patients will be unlike them. Maybe sicker, maybe less sick -- but different.
I keep thinking I should write a book about this. But I have no Credentials so it would have to be self-published.
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branchandroot
Re: Randomized clinical trial
Date: 2025-04-16 06:37 pm (UTC)Another measure to look at is, of the patients who were screened and willing to participate, what percentage were found eligible to participate (whether they ultimately agreed to or not)? If 90% of screened people were eligible, great. If only 20% of screened people with the condition to be treated were eligible, that means it is a highly selected group and most patients will be unlike them. Maybe sicker, maybe less sick -- but different.
I keep thinking I should write a book about this. But I have no Credentials so it would have to be self-published.