3 ms·
Regardless of the validity of the "user manual" metaphor, it's a pretty thin manual. At the phase 1 trial, you basically have some data from cell lines, mice an
by timr 3y ago
Regardless of the validity of the "user manual" metaphor, it's a pretty thin manual. At the phase 1 trial, you basically have some data from cell lines, mice and other small mammals, and maybe a few early humans. You can't infer much of anything from that.
To a first approximation, about half of drug candidates fail in each phase of development (i.e. 50% drop off in every phase, from 1 to 3). Naïvely, then, about 80% of compounds tested in phase 1 will fail to become drugs.
- s1artibartfast 3y agoI'm aware. I'm saying where the data is, to the extent it is available. I also don't why you think the doctor was giving false hope, or being less than candid. I think it is pretty clear that the author knows phase 1 studies are not well characterized and or proven effective.
- timr 3y agoWell, first: I didn't say anything about anyone being "less than candid". I don't believe that, or at least, don't have any reason to believe it from this post. I think people are talking their books, being overly optimistic, or just plain being arrogant. Second: regardless of what the author understands or does not, the quotes about oncologists pointing to their favorite trial, and the like, are not OK. The only valid answer is "we don't know", because literally every drug candidate in a phase 1 trial has some claim to plausibility outside of humans, yet most fail.
- s1artibartfast 3y agoI vehemently disagree that doctors should remain silent on their opinions. I think doing so would be very unethical and deceitful, by way of omission. However, they should be clear on what is option vs established consensus
- CogitoCogito 3y ago> I vehemently disagree that doctors should remain silent on their opinions. I think doing so would be very unethical and deceitful, by way of omission. But do those opinions have any scientific basis? If there isn’t any evidence of efficacy yet, then should a doctor say there is because it’s his or her opinion?
- s1artibartfast 3y agoNo the doctors shouldn't lie. However, rat studies, theory, experience, ect are all evidence. If you are navigating uncharted territory, your should listen to the opinion of your local guide. "I don't like that drug because every one of my patients that took it died horrible deaths" might not mean much statistically, but if there isn't any other data, I would want to know. Same if my doctor thinks a treatment is crazy and will never succeed.