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WELCOME: Introduce yourself & read the community guidelines

Admin Mon, Feb 19, 2024 at 5:20 PM 185 replies 24,631 viewsPage 1 of 20
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Feb 19, 2024 at 5:20 PM#1

WELCOME: Introduce yourself & read the community guidelines

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10 5PedsEndoPhilly, SleepDoc_PDX, RegAffairsDC and 7 others
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mike_nyc
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Feb 19, 2024 at 5:39 PM#2
Admin said:
WELCOME: Introduce yourself & read the community guidelines Welcome to Public Square.

Agreed, and subgroup analyses deserve particular suspicion. With enough subgroups something is significant by chance, and pre-registered subgroups are a different animal from ones found afterwards.

Happy to go further on any of that.

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FDA_TrackerJim
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Feb 19, 2024 at 5:57 PM#3
Admin said:
WELCOME: Introduce yourself & read the community guidelines Welcome to Public Square.

Pushing back on Admin here. I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them. The results probably generalise, and "probably" should be stated as an assumption rather than dropped.

Correct me if the detail matters more than I have assumed.

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Dr.PulmRoch
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Feb 19, 2024 at 6:16 PM#4

Short answer first, then the reasoning. Read four things before the headline number. The population, because trial populations are selected and supported in ways that real cohorts are not. The comparator, because "better than placebo" and "better than the current standard" are different claims and get reported identically. The primary endpoint as pre-registered, because a secondary endpoint promoted after the fact is a hypothesis rather than a finding. And the completion rate, because a large effect in the half of participants who finished is a different result from a large effect in everybody enrolled.

Last edited: Feb 19, 2024 at 7:16 PM
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VanRx_Mike
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Feb 19, 2024 at 7:57 PM#5
mike_nyc said:
Agreed, and subgroup analyses deserve particular suspicion.

Can confirm the pattern mike_nyc describes. Relative and absolute effects need reading together. A 20% relative reduction on a high baseline risk is a large absolute benefit; the same relative figure on a low baseline risk is a small one, and press summaries almost always quote the relative number because it is bigger.

Last edited: Feb 19, 2024 at 10:57 PM
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