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c/trialwatch·posted 2 years ago by u/yusuf_ramos

[Meta] proposal — a flair for FLOW posts

Readout Long Haul ×7 Slow Clap ×3 Clean Column ×3

proposal — a flair for FLOW posts, and it will stay as it is unless somebody makes the case to change it.

Open-label extensions lose their randomisation. Anybody still enrolled at week 104 is a selected group and the numbers describe that group.

Intention-to-treat analyses everybody randomised regardless of what they did afterwards. Completer analyses only those who finished. The second is systematically more flattering and both are legitimate if labelled.

A confidence interval is the range of effects compatible with the data. Two trials with overlapping intervals have not disagreed, whatever their point estimates look like next to each other.

Sceptical readings welcome. The confident ones are the ones I distrust.

8,951 up / 3,218 down74% upvoted24 commentsid 15kzid23 Nov 2023

24 comments

9 in this archive, depth 4

best — the order this archive was captured in

u/blunt_coldbox_notes647 points·2 years ago

Why comparing across trials almost never works, with the specific failure modes.

Different populations: an obesity programme and a diabetes programme enrol different people with different baseline characteristics. Different endpoints: body weight change, glycaemic control and cardiovascular events are not convertible. Different durations: 68 weeks and 72 weeks are not the same, and the curves have not flattened by either.

Different analysis populations: one paper reports intention-to-treat, another emphasises completers. Different support: some trial designs include structured lifestyle contact that no member of this board receives.

Stack those and the "X beats Y" tables that circulate here are comparing five things at once and attributing the difference to the molecule.

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u/oskar_ibarra949 points·2 years ago

Why comparing across trials almost never works, with the specific failure modes.

Adding the check nobody runs — the registered protocol is public and takes two minutes to compare.

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u/niels_norgaard-7 points·2 years ago

Right — trial participants get structured support. Comparing yourself to a trial mean is comparing across two different interventions.

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u/yusuf_ramosOP1 point·2 years ago

That is the 68-week readout, not the 72-week one. Different trial, different duration.

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u/pancreatitis_scare1 point·2 years ago

What was the discontinuation rate?

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u/iman_castellanos1 point·2 years ago

Agreed. Half the arguments on this site are two people quoting different trials at each other without noticing.

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u/yusuf_ramosOP-10 points·2 years ago

Right — trial participants get structured support.

Disagreeing with this line: that is a relative reduction and the absolute numbers are considerably less dramatic.

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u/naomi_ekstrom447 points·2 years ago

discontinuation rate is a result, not a footnote

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u/milos_vanhecke112 points·2 years ago

The registered protocol is public. Comparing the registered primary endpoint with the reported one is a two-minute check and it is how outcome switching gets caught.

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Clinical trial reading group. New readouts, protocol amendments, endpoint definitions, dropout handling, and the difference between a press release and a publication. Absolute risk reduction and number-needed-to-treat are house dialect here.

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