Accepted answer
The SUSTAIN-6 placebo arm is the only thing that makes its treatment arm interpretable, and it is the row nobody quotes. Symptoms reported under placebo in these programmes are not rare, because the population is being asked about them weekly and would have had some of them regardless. The attributable figure is the treated rate minus the placebo rate, and that difference is routinely a fraction of the headline. Two cautions on the subtraction: the arms must have been assessed the same way, and a discontinuation for an event removes that participant from later time points in both arms, which flatters whichever arm loses more people.
Answer first: read the primary endpoint, the comparator and the population before you read the effect size. Almost every argument on this site about a trial is really an argument about one of those three.
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.
Stated carefully, open-label extensions are not the same evidence as the randomised phase. Once everyone knows what they are taking, the reported outcomes acquire a bias that no analysis fully removes.
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.
If a claim cannot be traced to a named trial with a named endpoint, treat it as a claim rather than as evidence.
Thank you for separating the surrogate from the outcome. That distinction gets lost constantly. – bac_or_bust 7 months ago 8Which population was that figure from? It moves a lot between the trials. – pascal_thibault 5 months ago add a comment