To improve medical trials, justify exclusion criteria • Hacker News Board

Re: To improve medical trials, justify exclusion criteria

#51

Post by [deleted] » Wed, Apr 27, 2022, 12:33 AM UTC

gumby wrote: post #8

meowface wrote: post #2

>These unjustified exclusions can have real clinical implications, too. For example, most asthma studies exclude morbidly obese people, as morbidly obese asthma is notoriously resistant to treatment and there aren’t good explanations as to why. However, once asthma drugs are approved, they’re approved for all asthmatics equally. As a result, morbidly obese people get prescribed asthma drugs that were never tested on…

As someone who has both designed and run clinical trials as my job, this assertion is likely* nonsense. First, the division you submit to will reject your recruitment criteria if they feel it does not accurately reflect the treatment population within the United States. They also reflect the specialty of the particular division (e.g. Oncology is allegedly far less worried about most side effects than, say, the Dermat…

[deleted]

Re: To improve medical trials, justify exclusion criteria

#52

Post by refresherd » Wed, Apr 27, 2022, 3:14 AM UTC

meowface wrote: post #2

>These unjustified exclusions can have real clinical implications, too. For example, most asthma studies exclude morbidly obese people, as morbidly obese asthma is notoriously resistant to treatment and there aren’t good explanations as to why. However, once asthma drugs are approved, they’re approved for all asthmatics equally. As a result, morbidly obese people get prescribed asthma drugs that were never tested on…

Much like sleep apnea in the morbidly obese, this is likely just a different condition entirely with a physical cause.

As to why it is prescribed anyways - like the MD who taught me about sleep apnea said, morbidly obese people get offended when you suggest that there aren't drugs that you can give them and they just need to take some extra weight off the strained organs. It's easier to give a person who is certain that it's not the weight, but some condition solvable with drugs, a drug.

Re: To improve medical trials, justify exclusion criteria

#53

Post by puffoflogic » Wed, Apr 27, 2022, 3:17 AM UTC

refurb wrote: post #49

puffoflogic wrote: post #32

Earlier quoted context omitted.

It gives study staff the ability to exclude arbitrary sick patients from the trial. Combine this with a little harmless unblinding and the whole study outcome can be fabricated with plausible deniability. Notice that I'm referring exclusively to studies of prophylactics. The patient getting sick is the data point.

But trial arms need to be balanced, so excluding sick patients would stick out like a sore thumb. Of course you don’t allow patients to seek care elsewhere during a trial. If they went to their doctor and were prescribed some alternative therapy it would ruin all the data from that patient.

How can their being prescribed treatment retroactively ruin the data point that they got sick in the first place?

And moreover, unless trials are just standing by and watching patients die, the fact that a patient received X intervention and lived (or X and died) is the only kind of data trials of prophylactics can collect anyways. It doesn't really matter whether the treatment is administered by the trial since the treatment is not being studied.

Re: To improve medical trials, justify exclusion criteria

#54

Post by refurb » Wed, Apr 27, 2022, 4:23 AM UTC

puffoflogic wrote: post #53

refurb wrote: post #49

Earlier quoted context omitted.

But trial arms need to be balanced, so excluding sick patients would stick out like a sore thumb. Of course you don’t allow patients to seek care elsewhere during a trial. If they went to their doctor and were prescribed some alternative therapy it would ruin all the data from that patient.

How can their being prescribed treatment retroactively ruin the data point that they got sick in the first place? And moreover, unless trials are just standing by and watching patients die, the fact that a patient received X intervention and lived (or X and died) is the only kind of data trials of prophylactics can collect anyways. It doesn't really matter whether the treatment is administered by the trial since the…

Because interventions beyond those being tested are closely monitored. Many are excluded, diagnoses need to be confirmed by specific tests, certain treatments may be required to stay in the trial.

Trials usually run for a set period of time. If a patient gets outside treatment half way through, all data beyond that point (including the final analysis) is tainted. So likely the patient would be disqualified from the study and all their data discarded (and they would just show up as "n=1 patient withdrawn from study due to outside treatment for X").

A good example is an eczema trial. Patient gets drug and is monitored for 1 year. If that patient goes to an outside doctor because the rash got worse and gets a steroid cream, and get better, now you don't know - did the experimental drug help? or the steroid? or both? Was the rash actually worse? Or did the patient just think so? The treating doctor never saw the rash prior, so has no baseline. And they likely didn't score the severity of the rash so another data point could be captured.

It's all very standard a part of controlling variables in a trial.

Re: To improve medical trials, justify exclusion criteria

#55

Post by TameAntelope » Wed, Apr 27, 2022, 11:23 PM UTC

WalterBright wrote: post #48

TameAntelope wrote: post #22

Earlier quoted context omitted.

You dying to a disease is nobody's fault (usually). You dying to a bad drug is arguably someone's fault, and I suppose there are probably not any number of documents you can sign that will completely abdicate the responsibility for your death from the corporation that created the chemical compound that resulted in your demise. And probably for good reason? I really don't want to live in a society that gives people th…

The proper, moral, and correct thing to do is to allow each individual to decide for themselves after being presented with the facts on the risks, probabilities, and benefits. > I really don't want to live in a society In a free country, you don't really have the moral authority to make such decisions for other people. After all, you aren't wearing their shoes.

There is no moral way to let people decide for themselves if they want to be experimented on by pharmaceutical corporations.

In a free country, you absolutely have the moral authority (and imperative) to protect those who cannot protect themselves from being taken advantage of.