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Trials avoid high risk patients and underestimate drug harms

(www.nber.org)
174 points bikenaga | 3 comments | 08 Dec 25 19:07 UTC | HN request time: 0s | source
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randcraw ◴[08 Dec 25 21:00 UTC] No.46197600[source]▶
It's understandable that unusual patients are seen as confounding variables in any study, especially those with small numbers of patients. Though I haven't read beyond the abstract, it also makes sense that larger studies (phase 3 or 4) should not exclude such patients, but perhaps could report results in more than one way -- including only those with the primary malady as well as those with common confounding conditions.

Introducing too many secondary conditions in any trial is an invitation for the drug to fail safety and/or efficacy due to increased demands on both. And as we all know, a huge fraction of drugs fail in phase 3 already. Raising the bar further, without great care, will serve neither patients nor business.

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1. fwip ◴[09 Dec 25 04:32 UTC] No.46201256[source]▶
It seems like the current situation is doing a disservice to "unusual" patients (who may actually make up the majority of patients).
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2. doctorpangloss ◴[09 Dec 25 07:20 UTC] No.46202173[source]▶
how do you figure? absolute SAE rate increases 2 percentage points. nothing changes about relative SAE rate. does it change anything about your choice between different health technologies? no.
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3. fwip ◴[09 Dec 25 17:09 UTC] No.46207483[source]▶
The SAE rate increases 2 percentage points on average, as I understand it - not necessarily uniformly across interventions. It could be the case that medicine A has 4% SAE in healthy patients, and 5% in unhealthy* ones, whereas medicine B has 3% SAE in healthy and 6% in unhealthy - and without testing on unhealthy patients, you don't know that medicine B is riskier for those patients than A.

It could be that I'm totally misunderstanding, and that every medicine has the same elevation of risk of SAE for unhealthy patients, but that seems unlikely to me. You do have 'doctor' in your username though, so I'm probably embarrassing myself here.

*apologies for the healthy/unhealthy terminology, I don't know the right lingo to use here.