4 ms·
> On day 7, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 o
by sidkshatriya 3y ago
> On day 7, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 of 16) patients in Group 2 and 60% (9 of 15) patients in Group 3.
Ah ! It would have sucked to have Frostbite not be in Group 1 and then need to undergo amputation. Talk about bad luck ! However, I totally understand that this is the main way for the science to progress and treatments to get validated.
- yjftsjthsd-h 3y agoThe flip side is that it could have made things worse. Epistemology and ethics get complicated fast in this kind of thing:\
- idontknowifican 3y agothis is why PrEP has no double blind study. it was considered unethical
- A_D_E_P_T 3y agoIn the future this sort of thing will inevitably be viewed the way we view bloodletting with razors and leeches -- if not more harshly. They didn't know any better, way back when. We ought to know better. It's as simple as this: Double-blind, placebo-controlled studies are absolutely not required in drugs that are have extremely large effect sizes. In these cases, open-label trials, compassionate use programs, and post-marketing surveillance can be employed to continue gathering data on safety and efficacy without denying any patients access to critical treatments. And, in the end, the data you gather is just as useful, if not more useful.
- mlyle 3y ago3/32 vs 9/15 is -probably- a pretty big effect size, but I am not sure how you know that a priori without trying it on a couple dozen people first and comparing. They didn’t require huge n for approval, but it took a long time to just try it on a minimal number of patients.