
Medical Research: The Dangers to the Human Subjects - sergeant3
http://www.nybooks.com/articles/archives/2015/nov/19/medical-research-dangers-human-subjects
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medymed
This article compares medical experimentation with varying levels of
egregiousness, but leaves unmentioned the variable interpretation of the
standard of care used for control groups. Is the standard of care the regimen
that was outlined in the most-cited international guidelines published 6 years
ago, or is it the guideline supplemented by off-label drugs that have gained
widespread usage for their published increase in treatment efficacy but have
not made it into the guidelines yet, because the meeting to rewrite them is
next year? Things change fast in cancer and infectious disease and other
fields, so this becomes important when designing trials.

Anecdotally, it is also interesting to enroll patients in research/trials. The
idea of a fully-informed patient is incomplete in that patients are not
doctors specialising in their disease, so they will always be much less
informed about risks. Even if a patient hears a risk of a treatment is , for
example, aplastic anemia and is 'informed', it would take a few hours to
explain the possible consequences of that one side effect, much less the
others. Consequently, a lot of consenting to research or treatment protocols
involve an immense amount of trust. One patient was skeptical of a research
protocol until it was explained very carefully, after which I chatted with the
family for 1-2 hours waiting for the next blood draw and let them know that I
had put on my bow tie just to see them (which was true). Other patients just
don't even give hearing about it a shot, which is disheartening sometimes.

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tel
Informing patients is a hugely variable thing. It's "fast moving" at the
moment to make it more digitized at least, but that isn't always clearly the
best solution for patients even if it may be an improvement over the rushed PI
interview and boring training video.

I think what's exciting about clinical research—if only in principal!—is that
a doctor has an excuse to spend more time involved in a patient's life and
health. The idea of having an interview with the whole family discussing a
patient's health is pretty interesting even if it comes attached with the
additional burden of understanding an (often complex) trial protocol.

Unfortunately, I think that the idea of being able to schedule enough time for
such an interview (and doing so while wearing your best bow tie) is a rare
one.

