Unless there are compelling reasons to do things otherwise, most studies looking at a potential benefit from a new treatment or therapeutic approach will at first leave out all those who would potentially make the results less acceptable.
Hey, if you want more money for your research, if you want to be able to tell the world that something you’re working on is terrific, not just so-so, why would you risk a large negative component to your trial.
If you’re human, you wouldn’t, so it’s not ever a surprise, for example, that a new drug wasn’t tested on enough people with what we call co-morbidities – other significant medical conditions that the study participant might have and which might negatively impact the therapy that’s being tested.
So no surprise, I guess, that a recent study published in the Journal of General Internal Medicine concluded that “studies examining the effectiveness of treatments for COVID-19 often do not include the very populations hardest hit by the disease.”
These findings were based on an analysis of all US COVID-19 treatment trials registered on ClinicalTrials.gov (all decent American trials are now registered at this site).
So although COVID-19 has hit Black and Latino communities in the US much harder than it’s hit non-Latino white communities, the former were much less likely to be enrolled in ongoing US drug trials for SARS-CoV-2 treatments than were the former.
And although diabetes, for example, is a major risk factor for more severe COVID-19 infection, diabetic patients were much less likely to be enrolled in a drug trial in this pandemic than were non-diabetics.
So were women, so were lactating women, and on and on.
The researchers of such studies would likely argue that it’s better to leave out the very sick at first in order to establish that this might work in the more healthy first and only then risk it on the very ill.
Which is ass backwards, I suggest.
When people are dying from an illness, and you know who is most at risk, that’s precisely the people you should be aiming to include in your study.