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

genuine question about TRIUMPH that I am slightly embarrassed to ask

Trial Data Clean Column ×9 Cold Box ×1 Long Haul ×2

The title is the whole question — genuine question about TRIUMPH that I am slightly embarrassed to ask — but here is why I am asking.

Discontinuation rates are a tolerability result. A trial with a strong efficacy number and heavy discontinuation is telling you two things and people only quote one.

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.

Relative risk reduction without the baseline rate is uninterpretable. A large relative reduction on a small absolute risk is a small absolute benefit.

Not medical advice, obviously, and nothing here is approved for human use. One person with a spreadsheet.

5,287 up / 724 down88% upvoted48 commentsid 15uz4112 Dec 2023

48 comments

12 in this archive, depth 4

best — the order this archive was captured in

u/trialwatch_theoMOD657 points·2 years ago

Left up and flaired Trial Data. The publication is linked rather than the coverage, which is what we ask for.

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u/hazard_ratio_halstats279 points·2 years ago

FLOW was kidney outcomes and it is the one nobody quotes

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u/injection_site_iris-32 points·2 years ago

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

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u/enzo_ferrari1 point·2 years ago

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.

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u/ewan_tulloch256 points·2 years ago

Started keeping the trial identifiers straight in a note file because I kept mixing up two programmes in the same sentence.

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u/camila_vasquezOP146 points·2 years ago

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

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u/cold_chromatogram31111 points·2 years ago

Cardiovascular outcome trials are powered for events, not for weight, and are typically run in a different population with different inclusion criteria. Reading a weight number out of one is reading a secondary endpoint.

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u/adaeze_weiss79 points·2 years ago

Compared myself to a trial mean for about six months before realising the trial arm had dietitian contact every fortnight.

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u/whois_wanda90 points·2 years ago

SURPASS is the diabetes programme and reports glycaemic endpoints

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u/ferran_dahlberg116 points·2 years ago

intention to treat versus completers changes the number substantially

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u/camila_vasquezOP64 points·2 years ago

Which trial, and which arm?

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u/tove_ogunleye36 points·2 years ago

phase 2 finds a dose, phase 3 measures the effect

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