Editing Talk:2530: Clinical Trials

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:CTs cover "investigational" (just look how people are doing/have done under whatever course of treatment they might have, with no actual provision of anything new) and "interventional" (as above). A good study design will have a way to check the ongoing treatment (still blind/anonymised) and, if it warrants it (and it's not a review of historic data!), breaking the double-blind early and offering all subcohorts any treatment (or 'default') that has outperformed the other(s) being given. Useful both if the investigated drug is shown to be a 'miracle cure' ''or'' if it's a flop/worse than the old drug/has too many additional adverse events to be considered safe.
 
:CTs cover "investigational" (just look how people are doing/have done under whatever course of treatment they might have, with no actual provision of anything new) and "interventional" (as above). A good study design will have a way to check the ongoing treatment (still blind/anonymised) and, if it warrants it (and it's not a review of historic data!), breaking the double-blind early and offering all subcohorts any treatment (or 'default') that has outperformed the other(s) being given. Useful both if the investigated drug is shown to be a 'miracle cure' ''or'' if it's a flop/worse than the old drug/has too many additional adverse events to be considered safe.
 
:A modern trial (well... a decade ago, when I was work-adjacent to such trials, so picked up a lot from my colleagues who actually did trial design and management) probably covers all the points you suggest, all still under the same umbrella of "Clinical Trial". The exact specifics of how they proceded would depend a lot on what the trial was for, etc, and by the time Phase III (full clinical trials) were being started, the results of the Phase I/II (first-in-human/sub-theraputic tests) would have been concluded or wound up early (with sufficient success), giving a good idea of how much 'denied treatment' (or "given the prior treatment") is absolutely required, without being potentially excessive in caution.
 
:A modern trial (well... a decade ago, when I was work-adjacent to such trials, so picked up a lot from my colleagues who actually did trial design and management) probably covers all the points you suggest, all still under the same umbrella of "Clinical Trial". The exact specifics of how they proceded would depend a lot on what the trial was for, etc, and by the time Phase III (full clinical trials) were being started, the results of the Phase I/II (first-in-human/sub-theraputic tests) would have been concluded or wound up early (with sufficient success), giving a good idea of how much 'denied treatment' (or "given the prior treatment") is absolutely required, without being potentially excessive in caution.
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:And pretty much every one is bespoke. Trials of off-label uses, extending trials of adult-approved drugs to adolescents/children, or allowing their previously barred use in pregnant women. Restudying a drug that hadn't been tested ''at all'' in women (allowing for pesky hormone cycles, perhaps, which the men-only test had avoided). Intensively studying something truly life-saving (resuscitation methods, anti-AIDS treatments, pandemic vaccines) or quality-of-life extending (anti-dementia, treatments for Parkinsons, less traumatic chemotherapy). - Some, if not all, will consider how quickly the generously volunteering (or 'volunteered') control group might still be able to benefit from their originally being not-fully-treated (where possible, practical and proven as advantageous).
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:And pretty much every one is bespoke. Trials of off-label uses, extending trials of adult-approved drugs to adolescents/children, or allowing their previously barred use in pregnant women. Restudying a drug that hadn't been tested ''at all'' in women (allowing for pesky hormone cycles, perhaps, which the men-only test had avoided). Intensively studying something truly life-saving (resuscitation methods, anti-AIDS treatments, pandemic vaccines) or quality-of-life extending (anti-dementia, treatments for Parkinsons, less traumatic chemotherapy). - Some, if not all, will consider how quickly the generously volunteering (or 'volunteered' control group might still be able to benefit from their being not-fully-treated (where possible, practical and proven as advantageous).
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:But it's not something I was directly involved in, my responsibilities were in making sure that those with the more direct responsibilities could do their work properly, however it was they needed to in any given instance. I think I'd have been more stressed designing and managing a trial than I was (technically could affect ''numerous'' trials, or at least potentially increasing everyone else's stress values if I totally messed). I'm sure there's a more accurate/succinct explanation available. [[Special:Contributions/172.70.160.166|172.70.160.166]] 19:37, 26 March 2024 (UTC)
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:But it's not something I was ditectly involved in, my responsibilities were in making sure that those with the more direct responsibilities could do their work properly, however it was they needed to in any given instance. I think I'd have been more stressed designing and managing a trial than I was (technically could affect ''numerous'' trials, or at least potentially increasing everyone else's stress values if I totally messed). I'm sure there's a more accurate/succinct explanation available. [[Special:Contributions/172.70.160.166|172.70.160.166]] 19:37, 26 March 2024 (UTC)

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