4 ms·

There is no such thing as a standard placebo rate. If there was, there would be no need for every study to have a control group.

skrebbel 5y ago
So maybe that isn't what the GP meant? You're telling the person who did a study that they misunderstand the utter basics of studies, based on a 3-sentence comment they wrote.
- rictic 5y ago
  Sometimes people misunderstand the basics of their full time work yes We've all seen that person, and almost all of us have at times _been_ that person And unfortunately, given the replication crisis, there is no reason to assume that a published scientist is not making a fundamental error that undermines the validity of their work. It apparently happens quite frequently, and we should be quite grateful for those that question and probe at assumptions and potentially faulty analysis techniques
- deleted 5y ago
  [deleted]
mauricioc 5y ago
I understood it as "(standard placebo) rate", not "standard (placebo rate)". That is: "standard placebo" (tablets) << "new placebo format" (injection with no active components) < "real drug" (injection).
- deleted 5y ago
  [deleted]
gumby 5y ago
For the particular indication we were going after there had been a number of topical trials and academic studies that showed that the placebo response was less than 1%, essentially no different from spontaneous (i.e. no treatment). Same was true of oral. This is pretty common in fungal infections unfortunately. The FDA wanted us to compare against the topical treatment placebo rate for various technical reasons. Perhaps you thought that “standard” was some sort of standard for any placebo for any indication and any mode of administration? Indeed that would make no sense. Even specifying a placebo itself is non obvious. Of course your procedure and the object itself (tablet, whatever) is ideally indistinguishable by the study participant and, ideally the clinician (hard to do, say, when it’s a surgical procedure; you can’t hide that from the clinician). But even with a pill, you can’t always just supply, say, a slug of mannitol — that might actually affect what you’re studying.
- civilized 5y ago
  Thanks, this is helpful additional info. Sorry, I didn't mean to contradict you, I was actually trying to reinforce the principle behind your experience. There is no true "standard" for what sort of placebo should be used in a trial, even if something has become "standard" in the sense of commonly used. It is not something that can be specified in the abstract, but is a matter of expert judgment with many variables. Your trial gave an appropriate placebo, regardless of the "standard" in the field, and thus you were shielded from overstating the evidence of drug effectiveness.

skrebbel 5y ago

So maybe that isn't what the GP meant? You're telling the person who did a study that they misunderstand the utter basics of studies, based on a 3-sentence comment they wrote.

rictic 5y ago
Sometimes people misunderstand the basics of their full time work yes We've all seen that person, and almost all of us have at times _been_ that person And unfortunately, given the replication crisis, there is no reason to assume that a published scientist is not making a fundamental error that undermines the validity of their work. It apparently happens quite frequently, and we should be quite grateful for those that question and probe at assumptions and potentially faulty analysis techniques
deleted 5y ago
[deleted]

mauricioc 5y ago

I understood it as "(standard placebo) rate", not "standard (placebo rate)". That is: "standard placebo" (tablets) << "new placebo format" (injection with no active components) < "real drug" (injection).

deleted 5y ago
[deleted]

gumby 5y ago

For the particular indication we were going after there had been a number of topical trials and academic studies that showed that the placebo response was less than 1%, essentially no different from spontaneous (i.e. no treatment). Same was true of oral. This is pretty common in fungal infections unfortunately. The FDA wanted us to compare against the topical treatment placebo rate for various technical reasons. Perhaps you thought that “standard” was some sort of standard for any placebo for any indication and any mode of administration? Indeed that would make no sense. Even specifying a placebo itself is non obvious. Of course your procedure and the object itself (tablet, whatever) is ideally indistinguishable by the study participant and, ideally the clinician (hard to do, say, when it’s a surgical procedure; you can’t hide that from the clinician). But even with a pill, you can’t always just supply, say, a slug of mannitol — that might actually affect what you’re studying.

civilized 5y ago
Thanks, this is helpful additional info. Sorry, I didn't mean to contradict you, I was actually trying to reinforce the principle behind your experience. There is no true "standard" for what sort of placebo should be used in a trial, even if something has become "standard" in the sense of commonly used. It is not something that can be specified in the abstract, but is a matter of expert judgment with many variables. Your trial gave an appropriate placebo, regardless of the "standard" in the field, and thus you were shielded from overstating the evidence of drug effectiveness.