Accepted answer
Fair depends on the comparator arm, and in TRIUMPH-1 that means asking whether the comparator was titrated to the same ambition as the experimental one. A head-to-head that runs its comparator to a dose below the one it is licensed at is not measuring the two agents, it is measuring one agent against a handicapped version of the other. Check three things: the maximum comparator dose reached, the proportion of the comparator arm that reached it, and whether the titration schedules had the same duration. If those match, the comparison is fair on dosing and the argument moves to the endpoint. If they do not, the effect size is partly an artefact of the protocol.
Specifically, this is answerable from the published record, but only if you take the placebo arm seriously rather than reading the active arm alone.
Duration decides what can be seen. A 68-week trial can measure weight and glycaemia; it cannot measure anything whose event rate is one per cent per year without enrolling tens of thousands.
Relative to absolute, worked
| Quantity | Value | Derivation |
|---|
| Control-arm event rate | 8.0 % | From the trial table, not the abstract |
| Hazard ratio | 0.80 | Reported |
| Treated event rate | 6.4 % | 8.0 × 0.80 |
| Absolute risk reduction | 1.6 pp | 8.0 − 6.4 |
| Number needed to treat | 63 | 1 ÷ 0.016 |
| Relative risk reduction | 20 % | 1 − 0.80 |
The last two rows describe the same finding. Only one of them is used in headlines.
The part that matters: confidence intervals matter more than point estimates when two trials disagree. Two studies reporting fifteen and twenty per cent whose intervals overlap heavily have not disagreed about anything.
Registry entries at ClinicalTrials.gov carry the pre-specified primary endpoint with a timestamp, which is the cheapest available check on whether an endpoint was changed after the data were seen.
The caveat is that trial evidence is about licensed product administered under supervision. None of it transfers automatically to research-grade material of unverified content.
Read the protocol and the statistical analysis plan if the result matters to you. Both are usually published alongside.
7Same experience here, different supplier. – a_lindgren 6 months ago add a comment